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

September 8, 2026 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • New Zealand Clinical Research - Christchurch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: RO7875913
Participants will receive RO7875913.
Drug: RO7875913
Participants will receive RO7875913 as per the schedule described in the protocol.
Placebo Comparator: Part A: Placebo
Participants will receive placebo.
Drug: Placebo
Participants will receive placebo as per the schedule described in the protocol.
Experimental: Part B: RO7875913 with cevostamab
Participants will recieve RO7875913 with cevostamab.
Drug: RO7875913
Participants will receive RO7875913 as per the schedule described in the protocol.
Drug: Cevostamab
Participants will receive cevostamab as per the schedule described in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 3 months
Up to approximately 3 months
Part B: Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A: Serum concentration of RO7875913
Time Frame: Up to Day 76
Up to Day 76
Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
Time Frame: Baseline, Up to Day 76
Baseline, Up to Day 76
Part A: Recommended Phase II Dose (RP2D) of RO7875913
Time Frame: Up to approximately 3 months
Up to approximately 3 months
Part A: Observed Value of Pharmacodynamic Markers
Time Frame: Baseline, up to approximately 3 months
Baseline, up to approximately 3 months
Part B: Serum Concentration of RO7875913
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Serum Concentration of Cevostamab
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Objective Response Rate
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Rate of Very Good Partial Response (VGPR) or Better
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Duration of Response
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Time to First Response
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Time to Best Response
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

June 17, 2030

Study Completion (Estimated)

June 17, 2030

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO46451
  • 2026-526130-15-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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