A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
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).
Inclusion Criteria:

 -  Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.

 -  Dose Escalation 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.

 -  Dose Expansion Phase: Participants with r/r MM who have received at least three prior
 treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy.

 -  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 the last dose of study drug.

 -  Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate
 within 2 weeks before first RO7425781 administration.

 -  Prior treatment with systemic immunotherapeutic agents within 2 weeks before first
 RO7425781 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 except for alkylating
 agents (e.g., melphalan) within 28 days, prior to first RO7425781 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 RO7425781 administration and/or signs of chronic graft versus host disease or
 ongoing immunosuppressive medication.

 -  Prior solid organ transplantation.

 -  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.