NCT04776018 · OUTCOME

Phase 1b, Part 1, Vss: Volume of Distribution at Steady State for 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: liters
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

What was measured

Vss for TAK-981 was reported.

Analysis population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

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

Group	Source count
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg	2
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg	1
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg	7
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg	1
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg	4

Reported measurements

Source class 1

Values in liters · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg	377	5.1	Not reported	Not reported	Not reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg	281	NA	Not reported	Not reported	Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg	250	49.0	Not reported	Not reported	Not reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg	259	NA	Not reported	Not reported	Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg	331	20.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.1
value
377
comment
Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.
group Id
OG001
spread
NA
value
281
group Id
OG002
spread
49.0
value
250
comment
Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.
group Id
OG003
spread
NA
value
259
group Id
OG004
spread
20.4
value
331

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
7
group Id
OG003
value
1
group Id
OG004
value
4
units
Participants

description

Vss for TAK-981 was reported.

dispersion Type

Geometric Coefficient of Variation

groups

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
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
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
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
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

PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

title

Phase 1b, Part 1, Vss: Volume of Distribution at Steady State for TAK-981

type

SECONDARY

unit Of Measure

liters

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Preserved source evidence · Not medical advice