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Forimtamig · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib | EXPERIMENTAL | Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib | EXPERIMENTAL | Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib | EXPERIMENTAL | Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab | EXPERIMENTAL | Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab | EXPERIMENTAL | Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab | EXPERIMENTAL | Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. |
| Dose Expansion Phase: Forimtamig | EXPERIMENTAL | 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. |
| Dose Expansion Phase: Forimtamig + Carfilzomib | EXPERIMENTAL | Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression. |
| Dose Expansion Phase: Forimtamig + Daratumumab | EXPERIMENTAL | Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression. |
| Part I: Dose Escalation | EXPERIMENTAL | Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion. |
| Part II: Dose Expansion | EXPERIMENTAL | Dose 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Documented diagnosis of MM according to the IMWG diagnostic criteria * Evidence of progressive disease based on Investigator's determination of response by IMWG crit...
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Forimtamig is an investigational small molecule being developed for the treatment of multiple myeloma, specifically relapsed or refractory multiple myeloma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Forimtamig is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with multiple myeloma.
Forimtamig is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. Clinical trials are ongoing or completed to assess its safety, pharmacokinetics, and clinical activity in patients with relapsed or refractory multiple myeloma.
Forimtamig has been studied in two Phase 1 clinical trials. NCT04557150 evaluated escalating doses in 225 participants with relapsed or refractory multiple myeloma across multiple countries. NCT06055075 assessed Forimtamig-based treatment combinations in 19 participants with relapsed or refractory multiple myeloma.
Forimtamig is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for the treatment of relapsed or refractory multiple myeloma. Its safety and efficacy have not been established, and it remains under clinical investigation.