Forimtamig for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called Forimtamig on patients with a type of cancer called multiple myeloma. These patients have no other treatment options or cannot tolerate existing treatments. The drug aims to either kill the cancer cells or help the immune system fight them.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with relapsed or refractory Multiple Myeloma who've tried other treatments like IMiDs and PIs but can't use them anymore. They should have a life expectancy of at least 12 weeks, measurable disease, and be willing to follow birth control guidelines. People can't join if they're pregnant, breastfeeding, recently used certain cancer drugs or immunotherapies, had organ transplants, active autoimmune diseases, or stem cell transplantation within the last 100 days.

Inclusion Criteria

I agree to provide tissue samples for the study.

I have relapsed/refractory multiple myeloma and cannot tolerate or have no other standard treatments left.

I have been diagnosed with Multiple Myeloma.

See 5 more

Exclusion Criteria

I haven't taken any antibody treatments for my MM in the last 2 weeks.

I haven't taken any immune system treatments in the last 2 weeks.

I had a stem cell transplant within the last 100 days or have ongoing signs of graft versus host disease.

See 7 more

Treatment Details

Interventions

RO7425781 (Monoclonal Antibodies)

Trial OverviewThe study tests escalating doses of Forimtamig in two parts: first finding the right dose (Part 1) and then giving that dose to more people to see how well it works (Part 2). It's for patients with no standard treatment options left or those intolerant to existing therapies.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Part II: Dose ExpansionExperimental Treatment1 Intervention

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.

Group II: Part I: Dose EscalationExperimental Treatment1 Intervention

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