An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

BP43437

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.

2023-12-12

2027-06-10

2027-06-10

Recruiting

Early phase I

316

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 criteria on or after last dosing regimen * Measurable disease * AEs from prior anti-cancer therapy resolved to Grade ≤ 1, * Adequate organ functions Exclusion Criteria: * Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug * Plasma cell leukemia with circulating plasma cell count ≥ 5% or \>500/microliter (µL) * Participants with known amyloidosis * Participants with myelodysplastic syndrome * Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter * Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration * Prior solid organ transplantation * Active auto-immune disease or flare within 6 months prior to start of study treatment * Known or suspected chronic active Epstein-Barr virus (EBV) infection * Hepatitis B virus (HBV) infection * Acute or chronic hepatitis C virus (HCV) infection * Known history of HIV seropositivity * Live vaccine(s) within one month prior to start of the treatment * Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations * Previous refractoriness to carfilzomib * Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity * Participants with known liver cirrhosis * Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 316, 'type': 'ESTIMATED'}}

2024-04-16