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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002012-46 | EudraCT Number | ||
| 2023-504571-25-00 | EU Trial (CTIS) Number |
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This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forimtamig | Drug | Forimtamig 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 104 weeks | |
| Duration of Response (DOR) | Up to 104 weeks | |
| Progression-Free Survival (PFS) |
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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 |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia | ||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39476124 | Derived | Eckmann J, Fauti T, Biehl M, Zabaleta A, Blanco L, Lelios I, Gottwald S, Rae R, Lechner S, Bayer C, Dekempe Q, Osl F, Carrie N, Kassem S, Lorenz S, Christopeit T, Carpy A, Bujotzek A, Broske AM, Dekhtiarenko I, Attig J, Kunz L, Cremasco F, Adelfio R, Fertig G, Dengl S, Gassner C, Bormann F, Kirstenpfad C, Kraft T, Diggelmann S, Knobloch M, Hage C, Feddersen R, Heidkamp G, Poschinger T, Mayoux M, Bernasconi L, Prosper F, Dumontet C, Martinet L, Leclair S, Xu W, Paiva B, Klein C, Umana P. Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. Blood. 2025 Jan 9;145(2):202-219. doi: 10.1182/blood.2024025987. |
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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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|
| Up to 104 weeks |
| Overall Survival (OS) | Up to 104 weeks |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig | Up to 104 weeks |
| Maximum Concentration (Cmax) of Forimtamig | Up to 104 weeks |
| Time of Maximum Concentration (Tmax) of Forimtamig | Up to 104 weeks |
| Minimum Concentration (Cmin) of Forimtamig | Up to 104 weeks |
| SC Bioavailability (F) of Forimtamig | Up to 104 weeks |
| Apparent Clearance (CL/F) of Forimtamig | Up to 104 weeks |
| Volume of Distribution at Steady State (Vss) of Forimtamig (IV only) | Up to 104 weeks |
| Area Under the Curve (AUC) at Various Time Intervals of Forimtamig | Up to 104 weeks |
| Ghent |
| 9000 |
| Belgium |
| Rigshospitalet | København Ø | 2100 | Denmark |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| CHRU Lille - Hôpital Claude Huriez | Lille | 59037 | France |
| CHU NANTES - Hôtel Dieu | Nantes | 44093 | France |
| Hopital De Haut Leveque | Pessac | 33604 | France |
| IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica | Naples | Campania | 80131 | Italy |
| Policlinico S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Fond. IRCCS Istituto Nazionale Tumori | Milan | Lombardy | 20133 | Italy |
| Instituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| New Zealand Clinical Research - Auckland | Auckland | 1010 | New Zealand |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | W1T 7HA | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| 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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