A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

Roche

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Forimtamig

Study type: Interventional

Funder types: Industry

Identifiers

NCT04557150

2020-002012-46 (EudraCT Number)

2023-504571-25-00 (Registry Identifier)

BP42233

Details and patient eligibility

About

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).

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
• Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
• Life expectancy of at least 12 weeks.
• Agreement to provide protocol-specific biopsy material.
• AEs from prior anti-cancer therapy resolved to Grade =<1.
• Measurable disease.
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion criteria

• Inability to comply with protocol-mandated hospitalization and activities restrictions.
• Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
• Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
• Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
• Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
• Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
• Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
• Prior solid organ transplantation.
• Active auto-immune disease or flare within 6 months prior to start of study treatment
• Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

225 participants in 2 patient groups

Part I: Dose Escalation

Experimental group

Description:

Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Treatment:

Drug: Forimtamig

Part II: Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: Forimtamig