A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT06055075

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2025-07-08

Brief Summary

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib

Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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

Intervention Type: DRUG

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib

Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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

Intervention Type: DRUG

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib

Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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

Intervention Type: DRUG

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab

Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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.

Daratumumab

Intervention Type: DRUG

Daratumumab will be administered via SC injection in combination with forimtamig.

Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab

Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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.

Daratumumab

Intervention Type: DRUG

Daratumumab will be administered via SC injection in combination with forimtamig.

Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab

Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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.

Daratumumab

Intervention Type: DRUG

Daratumumab will be administered via SC injection in combination with forimtamig.

Dose Expansion Phase: Forimtamig

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.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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.

Dose Expansion Phase: Forimtamig + Carfilzomib

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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

Intervention Type: DRUG

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Dose Expansion Phase: Forimtamig + Daratumumab

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.

Group Type: EXPERIMENTAL

Forimtamig

Intervention Type: 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.

Daratumumab

Intervention Type: DRUG

Daratumumab will be administered via SC injection in combination with forimtamig.

Interventions

Forimtamig

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.

Intervention Type: DRUG

Carfilzomib

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Intervention Type: DRUG

Daratumumab

Daratumumab will be administered via SC injection in combination with forimtamig.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Hamilton Health Sciences

Hamilton, Ontario, Canada

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

New Zealand Clinical Research - Auckland

Auckland, , New Zealand

Seoul St Mary's Hospital

Seoul, , South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Countries

Australia; Canada; Italy; New Zealand; South Korea; Spain

Other Identifiers

2023-503689-21-00

Identifier Type: CTIS

Identifier Source: secondary_id

BP43437

Identifier Type: -

Identifier Source: org_study_id