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NCT04776018 · OUTCOME

Phase 1b, Part 1: Observed Plasma Concentration of TAK-981

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-10-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
nanograms per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1: Pre-dose, at end of infusion (EOI), 2, 4, 6, and 24 hours post-dose; Cycle 1 Days 8 and 15: Pre-dose and EOI; Cycle 2 Days 1 and 15: Pre-dose and EOI (Cycle length = 28 days)

What was measured

Observed plasma concentration of TAK-981 was reported.

Analysis population: Pharmacokinetic (PK) analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" signifies participants evaluable at specified time-point.

Groups in this outcome

Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg

Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg

Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg8

Reported measurements

Cycle 1 Day 1: Predose

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg8
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Cycle 1 Day 1: EOI

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg9
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg6
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg22544.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg642NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg61761.7Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1120NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg84227.5Not reportedNot reportedNot reported
Cycle 1 Day 1: 2 hours

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg79.451.7Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg11027.8Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg11549.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg13947.9Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg11638.3Not reportedNot reportedNot reported
Cycle 1 Day 1: 4 hours

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg37.545.7Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg63.037.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg69.662.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg63.218.9Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg56.538.9Not reportedNot reportedNot reported
Cycle 1 Day 1: 6 hours

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg0
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg0
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg0
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg31.065.4Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg33.2NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Cycle 1 Day 1: 24 hours

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg9
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3.2768.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg5.9112.9Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg4.7554.0Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg5.5141.2Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg6.2957.7Not reportedNot reportedNot reported
Cycle 1 Day 8: Predose

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0.51962.6Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg0.41178.8Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Cycle 1 Day 8: EOI

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg6
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg31884.6Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg57617.1Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg82952.7Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg136041.1Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg107045.4Not reportedNot reportedNot reported
Cycle 1 Day 15: Predose

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg8
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg6
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg0.17728.8Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0.7581139.8Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Cycle 1 Day 15: EOI

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg6
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg5
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg28138.1Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg58541.8Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg81255.5Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg830NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg94024.6Not reportedNot reportedNot reported
Cycle 2 Day 1: Predose

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg5
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg6
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Cycle 2 Day 1: EOI

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg5
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg3
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg21213.1Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg84438.5Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg76761.6Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1580NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg8208.7Not reportedNot reportedNot reported
Cycle 2 Day 15: Predose

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg5
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg0.18234.9Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0.536NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg0.286NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mgNANANot reportedNot reportedGeometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Cycle 2 Day 15: EOI

Analysis denominator · Participants

GroupSource count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg2
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg4
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg191NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg63446.3Not reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1500NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg71314.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG004
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        8
      units
      Participants
    title
    Cycle 1 Day 1: Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.3
        value
        225
      2. comment
        Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
        group Id
        OG001
        spread
        NA
        value
        642
      3. group Id
        OG002
        spread
        61.7
        value
        617
      4. comment
        Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
        group Id
        OG003
        spread
        NA
        value
        1120
      5. group Id
        OG004
        spread
        27.5
        value
        842
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        6
      units
      Participants
    title
    Cycle 1 Day 1: EOI
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.7
        value
        79.4
      2. group Id
        OG001
        spread
        27.8
        value
        110
      3. group Id
        OG002
        spread
        49.3
        value
        115
      4. group Id
        OG003
        spread
        47.9
        value
        139
      5. group Id
        OG004
        spread
        38.3
        value
        116
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Cycle 1 Day 1: 2 hours
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.7
        value
        37.5
      2. group Id
        OG001
        spread
        37.3
        value
        63.0
      3. group Id
        OG002
        spread
        62.3
        value
        69.6
      4. group Id
        OG003
        spread
        18.9
        value
        63.2
      5. group Id
        OG004
        spread
        38.9
        value
        56.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Cycle 1 Day 1: 4 hours
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.4
        value
        31.0
      2. comment
        Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
        group Id
        OG001
        spread
        NA
        value
        33.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1: 6 hours
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.3
        value
        3.27
      2. group Id
        OG001
        spread
        12.9
        value
        5.91
      3. group Id
        OG002
        spread
        54.0
        value
        4.75
      4. group Id
        OG003
        spread
        41.2
        value
        5.51
      5. group Id
        OG004
        spread
        57.7
        value
        6.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Cycle 1 Day 1: 24 hours
  7. categories
    1. measurements
      1. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        62.6
        value
        0.519
      3. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG002
        spread
        NA
        value
        NA
      4. group Id
        OG003
        spread
        78.8
        value
        0.411
      5. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG004
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Cycle 1 Day 8: Predose
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.6
        value
        318
      2. group Id
        OG001
        spread
        17.1
        value
        576
      3. group Id
        OG002
        spread
        52.7
        value
        829
      4. group Id
        OG003
        spread
        41.1
        value
        1360
      5. group Id
        OG004
        spread
        45.4
        value
        1070
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        7
      units
      Participants
    title
    Cycle 1 Day 8: EOI
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.8
        value
        0.177
      2. group Id
        OG001
        spread
        1139.8
        value
        0.758
      3. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG004
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        6
      units
      Participants
    title
    Cycle 1 Day 15: Predose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.1
        value
        281
      2. group Id
        OG001
        spread
        41.8
        value
        585
      3. group Id
        OG002
        spread
        55.5
        value
        812
      4. comment
        Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
        group Id
        OG003
        spread
        NA
        value
        830
      5. group Id
        OG004
        spread
        24.6
        value
        940
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      units
      Participants
    title
    Cycle 1 Day 15: EOI
  11. categories
    1. measurements
      1. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG003
        spread
        NA
        value
        NA
      5. comment
        Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
        group Id
        OG004
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        6
      units
      Participants
    title
    Cycle 2 Day 1: Predose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.1
        value
        212
      2. group Id
        OG001
        spread
        38.5
        value
        844
      3. group Id
        OG002
        spread
        61.6
        value
        767
      4. comment
        Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
        group Id
        OG003
        spread
        NA
        value
        1580
      5. group Id
        OG004
        spread
        8.7
        value
        820
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1: EOI
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      8
    units
    Participants
description
Observed plasma concentration of TAK-981 was reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG000
    title
    Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg
  2. description
    Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG001
    title
    Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg
  3. description
    Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG002
    title
    Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg
  4. description
    Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG003
    title
    Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg
  5. description
    Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG004
    title
    Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" signifies participants evaluable at specified time-point.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: Pre-dose, at end of infusion (EOI), 2, 4, 6, and 24 hours post-dose; Cycle 1 Days 8 and 15: Pre-dose and EOI; Cycle 2 Days 1 and 15: Pre-dose and EOI (Cycle length = 28 days)
title
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice