Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This trial will be conducted in two parts: Dose-escalation (Part 1) and randomised Dose Expansion (Part 2). Eligible patients will receive intravenous and/or subcutaneous RO7425781 either in a set up dosing fashion (Part 1) or at the maximum tolerated/Recommended Phase 2 Dose (Part 2).
Conditions
This trial is treating people with multiple myeloma
Eligibility
Inclusion
- 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
- 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 the 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific Title
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma
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