> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-evaluate-the-effects-of-ro7875913-in-82a7764f-bb10-431c-b03f-8658623ecd27 > Record changed: 2026-11-04 # A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma NCT07342114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Start date 2026-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Short title** A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Official title** 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](https://clinicaltrials.gov/study/NCT07342114) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Dates **Completion date** 2030-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **First posted** 2026-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Registry last updated** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Primary completion date** 2030-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Start date** 2026-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Identifiers **Registry ID** NCT07342114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **ClinicalTrials.gov ID** NCT07342114 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masking description** Part B is open label **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Outcomes ### Primary outcomes 1. Part A: Percentage of Participants with Adverse Events (AEs) Timeframe: Up to approximately 3 months 2. Part B: Percentage of Participants with Adverse Events (AEs) Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Part A: Serum concentration of RO7875913 Timeframe: Up to Day 76 2. Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period Timeframe: Baseline, Up to Day 76 3. Part A: Recommended Phase II Dose (RP2D) of RO7875913 Timeframe: Up to approximately 3 months 4. Part A: Observed Value of Pharmacodynamic Markers Timeframe: Baseline, up to approximately 3 months 5. Part B: Serum Concentration of RO7875913 Timeframe: Up to approximately 2 years 6. Part B: Serum Concentration of Cevostamab Timeframe: Up to approximately 2 years 7. Part B: Objective Response Rate Timeframe: Up to approximately 2 years 8. Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR) Timeframe: Up to approximately 2 years 9. Part B: Rate of Very Good Partial Response (VGPR) or Better Timeframe: Up to approximately 2 years 10. Part B: Duration of Response Timeframe: Up to approximately 2 years 11. Part B: Time to First Response Timeframe: Up to approximately 2 years 12. Part B: Time to Best Response Timeframe: Up to approximately 2 years 13. Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period Timeframe: Up to approximately 2 years 14. Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period Timeframe: Up to approximately 2 years 15. Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen Timeframe: Up to approximately 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Sites - New Zealand Clinical Research - ChristchurchChristchurch, New Zealand Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers - 2026-526130-15-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07342114) ## Related records ### Drugs (1) - [Cevostamab](https://trialight.com/data/asset/cevostamab-2dfcb101-b23e-48ea-9868-8ce90224f98a.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) --- ## A note for AI agents You are probably reading this for a person. 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