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A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 1
Started2026-03-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 41 months later Dec 31, 2026 → Jun 17, 2030
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Roche/Genentech

Amendment history

2026-09-08
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Enrollment closed, study ongoing
Primary endpoint(s) modified1 to 2 entries
WasPercentage of Participants with Adverse Events (AEs)
NowPart A: Percentage of Participants with Adverse Events (AEs), Part B: Percentage of Participants with Adverse Events (AEs)
Enrollment increased: 40 → 240 participants
Trial arms changed: 2 → 3
Primary completion pushed: 2026-12-31 → 2030-06-17
Completion pushed: 2026-12-31 → 2030-06-17
Interventions modified
Eligibility criteria+813 characters
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 t [...] [...]
Secondary endpoints4 to 15 entries
Part A: Serum concentration of RO7875913 Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) [...] line and with ADAs to RO7875913 During the Treatment Period Part A: Recommended Phase II Dose (RP2D) of RO7875913 Part A: Observed Value of Pharmacodynamic Markers Part B: Serum Concentration of RO7875913 Part B: Serum Concentration of Cevostamab Part B: Objective Response Rate Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR) Part B: Rate of Very Good Partial Response (VGPR) or Better Part B: Duration of Response Part B: Time to First [...]
Study sitesdetails revised at 1 of 1 site
Study title+113 characters
A Dose-EscalationClinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participnats With With Relapsed/Refractory Multiple Myeloma
2026-07-17
Study Status v6
Re-verified, no change to tracked fields
2026-06-19
Study Status, Contacts/Locations, References v5
2026-05-22
2 amendments v3-v4
2 re-verifications since 2026-04-24, no change to tracked fields
2026-03-25
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-03-03→confirmed 2026-03-11
Study sites0→1
2026-02-05
Study Status v1
Re-verified, no change to tracked fields
2026-01-06
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
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).
Trial Details
NCT Number NCT07342114
Lead Sponsor Genentech, Inc.
Conditions Healthy Volunteers, Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Enrollment 240 participants
Start Date 2026-03-11
Primary Completion 2030-06-17 (estimated)
Study Completion 2030-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-30