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NCT03439280 · OUTCOME

Phase 1: RP2D of TAK-079

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM) · Source last updated 2023-02-24

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)

What was measured

RP2D was determined by dose escalating monotherapy groups.

Analysis population: DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.

Groups in this outcome

Phase 1 Dose Escalation Cohort: Mezagitamab

Mezagitamab SC, at escalating doses ranging from 45 mg to 1200 mg once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.

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 1 Dose Escalation Cohort: Mezagitamab37

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Dose Escalation Cohort: Mezagitamab600Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        600
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
RP2D was determined by dose escalating monotherapy groups.
groups
  1. description
    Mezagitamab SC, at escalating doses ranging from 45 mg to 1200 mg once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
    id
    OG000
    title
    Phase 1 Dose Escalation Cohort: Mezagitamab
param Type
NUMBER
population Description
DLT-evaluable analysis set included participants who received all Cycle 1 doses of mezagitamab and completed Cycle 1 procedures or experienced a DLT in Cycle 1.
reporting Status
POSTED
time Frame
From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)
title
Phase 1: RP2D of TAK-079
type
SECONDARY
unit Of Measure
mg

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice