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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503689-21-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 24 months | |
| Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria | Up to approximately 24 months | |
| Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months | |
| Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months | |
| Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital Woolloongabba | Woolloongabba | Queensland | 4102 | Australia | ||
| Royal Adelaide Hospital |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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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. |
|
| 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. |
|
| Up to approximately 24 months |
| Time to First Response as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Time to Best Response as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Overall Survival (OS) as Determined by the Investigator per IMWG Criteria | Up to approximately 24 months |
| Serum Concentration of Forimtamig | Up to approximately 24 months |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig | Up to approximately 24 months |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| New Zealand Clinical Research - Auckland | Auckland | 1010 | New Zealand |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C524865 | carfilzomib |
| C556306 | daratumumab |
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