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NCT06055075 · FLOW

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A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-29

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

groups
  1. description
    Participants received step-up doses of forimtamig 0.03 milligrams (mg) on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a subcutaneous (SC) injection. Participants also received carfilzomib, 20 milligrams per square meter (mg/m\^2) on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an intravenous (IV) infusion (1 cycle = 28 days).
    id
    FG000
    title
    Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
  2. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    FG001
    title
    Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
  3. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    FG002
    title
    Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Study Terminated by Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Did not Start Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      comment
      Safety population included all participants enrolled in the study who received any amount of any study treatment.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In dose exploration phase of the study, 3 forimtamig dose levels were to be tested in combination with carfilzomib or daratumumab \& selected forimtamig dose(s) were to continue in the expansion phase with the respective combination partner. However, since the Sponsor terminated the study prematurely, the dose exploration forimtamig + daratumumab \& the dose expansion phase arms were never opened for enrollment. All participants were enrolled in dose exploration forimtamig + carfilzomib arms only.
recruitment Details
A total of 21 participants with relapsing or refractory multiple myeloma (r/r MM) took part in the study at 9 investigative sites across Korea, Australia, Italy, New Zealand, Canada, and Spain from 08 December 2023 to 08 July 2025.
Complete source fields
groups
  1. description
    Participants received step-up doses of forimtamig 0.03 milligrams (mg) on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.3 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a subcutaneous (SC) injection. Participants also received carfilzomib, 20 milligrams per square meter (mg/m\^2) on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an intravenous (IV) infusion (1 cycle = 28 days).
    id
    FG000
    title
    Cohort 1: Arm B1: Forimtamig 0.3 mg + Carfilzomib
  2. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 0.75 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    FG001
    title
    Cohort 1: Arm B2: Forimtamig 0.75 mg + Carfilzomib
  3. description
    Participants received step-up doses of forimtamig, 0.03 mg on Cycle 1 Day 1, 0.15 mg on Cycle 1 Day 8, and the target dose of 1.5 mg on Cycle 1 Day 15 and on Days 1 and 15 of each subsequent cycle, administered as a SC injection. Participants also received carfilzomib, 20 mg/m\^2 on Cycle 2 Day 1 and 56 mg/m\^2 on Cycle 2 Days 8 and 15, and from Cycle 3 onwards on Days 1, 8, and 15, administered as an IV infusion (1 cycle = 28 days).
    id
    FG002
    title
    Cohort 1: Arm B3: Forimtamig 1.5 mg + Carfilzomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Study Terminated by Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Did not Start Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        6
      comment
      Safety population included all participants enrolled in the study who received any amount of any study treatment.
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In dose exploration phase of the study, 3 forimtamig dose levels were to be tested in combination with carfilzomib or daratumumab \& selected forimtamig dose(s) were to continue in the expansion phase with the respective combination partner. However, since the Sponsor terminated the study prematurely, the dose exploration forimtamig + daratumumab \& the dose expansion phase arms were never opened for enrollment. All participants were enrolled in dose exploration forimtamig + carfilzomib arms only.
recruitment Details
A total of 21 participants with relapsing or refractory multiple myeloma (r/r MM) took part in the study at 9 investigative sites across Korea, Australia, Italy, New Zealand, Canada, and Spain from 08 December 2023 to 08 July 2025.

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Preserved source evidence · Not medical advice