A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor
Hoffmann-La Roche
Study ID
NCT06055075
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Forimtamig — DRUG
    Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.
  • Carfilzomib — DRUG
    Carfilzomib will be administered via IV infusion in combination with forimtamig.
  • Daratumumab — DRUG
    Daratumumab will be administered via SC injection in combination with forimtamig.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

Key Dates

Start date
Dec 12, 2023
Status verified
Jul 2025
Primary completion
Jul 8, 2025
Completion
Jul 8, 2025

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
    Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.
  • Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
    Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
  • Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
    Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
  • Experimental: Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
    Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
  • Experimental: Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
    Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
  • Experimental: Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
    Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
  • Experimental: Dose Expansion Phase: Forimtamig
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.
  • Experimental: Dose Expansion Phase: Forimtamig + Carfilzomib
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.
  • Experimental: Dose Expansion Phase: Forimtamig + Daratumumab
    Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]

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