About the study

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. RO7425781 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 RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (Part 2).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
2. 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.
3. Life expectancy of at least 12 weeks.
4. Agreement to provide protocol-specific biopsy material.
5. AEs from prior anti-cancer therapy resolved to Grade =<1.
6. Measurable disease.
7. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
8. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion criteria

1. Inability to comply with protocol-mandated hospitalization and activities restrictions.
2. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study drug.
3. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first RO7425781 administration.
4. Prior treatment with systemic immunotherapeutic agents within 2 weeks before first RO7425781 administration.
5. Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
6. Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first RO7425781 administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
7. Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first RO7425781 infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
8. Prior solid organ transplantation.
9. Active auto-immune disease or flare within 6 months prior to start of study treatment
10. 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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.