Clinical trial · Interventional
A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participnats With With Relapsed/Refractory Multiple Myeloma
A Phase Ia/Ib, Multicenter, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RO7875913 in Healthy Volunteers and to Assess Its Preliminary Activity in Combination With Cevostamab In Patients With Relapsed Or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
Part A: The purpose of Part A of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants. Part B: The purpose of Part B of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7875913 administered in combination with the T cell-engaging bispecific antibody (TCB) cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cevostamab | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| RO7875913 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part A: RO7875913
- description
- Participants will receive RO7875913.
- interventionNames
- Drug: RO7875913
- type
- PLACEBO_COMPARATOR
- label
- Part A: Placebo
- description
- Participants will receive placebo.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Part B: RO7875913 with cevostamab
- description
- Participants will recieve RO7875913 with cevostamab.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: General: * Agreement to adhere to the contraception requirements Part A: * Body weight \> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m\^2) Part B: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Agreement to provide bone marrow biopsy and aspirate samples Exclusion Criteria: General: * Treatment with any vaccine within 4 weeks prior to initiation of study drug, or vaccination scheduled to occur during the study * History or current cardiovascular or pulmonary disease that may limit the ability to respond to systemic infusion/injection reactions * Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen * History of any malignancy * Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders * Known allergy or hypersensitivity to any component of the RO7875913 formulation Part A: * Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug * Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug * Clinically apparent or familial history of autoimmune disease Part B: * Treatment with any systemic chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment * Treatment with any immunosuppressive medication within 2 weeks prior to first dose of study treatment * Absolute plasma cell count exceeding 500/mL or 5% of the peripheral blood white cells
References
Publications (0)
Data not yet available