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Forimtamig

Phase 1

Multiple Myeloma | Small molecule | Oncology |Roche Holding AG|Trials Updated: Apr 13, 2026

Forimtamig development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2020

Forimtamig target and mechanism

ModalitySmall molecule

Also known as RO7425781

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment225

FDA Designations

No designations recorded

Forimtamig clinical trials

Forimtamig · 1 trial · 1 indication

Phase 1 1
NCT04557150A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)Multiple Myeloma
COMPLETED225 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events (AEs)
Up to 104 weeks
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Cycle 1 Day 1 up to Cycle 1 Day 35

Secondary Endpoints

Objective Response Rate (ORR)
Up to 104 weeks
Duration of Response (DOR)
Up to 104 weeks
Progression-Free Survival (PFS)
Up to 104 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part I: Dose EscalationEXPERIMENTALParticipants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
Part II: Dose ExpansionEXPERIMENTALDose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.

Interventions

NameTypeDescription
ForimtamigDRUGForimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Previously diagnosed with Multiple Myeloma (MM) based on standard criteria. * Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to ...

Countries:AustraliaBelgiumDenmarkFranceItalyNew ZealandSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Multiple Myeloma 338 trials

Frequently asked questions about Forimtamig

What is Forimtamig used for?

Forimtamig is an investigational therapy being studied for relapsed or refractory multiple myeloma, a cancer of plasma cells in the bone marrow. It is not approved for any indication and remains in clinical development. The Phase 1 study enrolled adults with relapsed or refractory multiple myeloma across sites in Australia, Belgium, Denmark, France, Italy, New Zealand, South Korea, Spain, and the United Kingdom.

Who is developing Forimtamig?

Forimtamig is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in multiple myeloma.

What phase is Forimtamig in?

Forimtamig is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a controlled, randomized, non-double-blind trial that enrolled 225 participants with relapsed or refractory multiple myeloma.

What clinical trials is Forimtamig in?

Forimtamig has been evaluated in one completed Phase 1 trial, NCT04557150, titled A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma. The trial enrolled 225 adults aged 18 years and older, across both sexes, and was conducted in nine countries.

Is Forimtamig FDA approved?

Forimtamig is not FDA approved. It is an investigational drug still in clinical development, with only a completed Phase 1 trial in relapsed or refractory multiple myeloma. No regulatory approval has been granted for any indication.