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 | Active Not Recruiting Phase 1

• 2 other identifiers: GO464512026-526130-15-00
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteers; Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Part A: Percentage of Participants with Adverse Events (AEs)

  Up to approximately 3 months

• Part B: Percentage of Participants with Adverse Events (AEs)

  Up to approximately 2 years

Secondary Outcomes (15)

• Part A: Serum concentration of RO7875913

  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

  Baseline, Up to Day 76

• Part A: Recommended Phase II Dose (RP2D) of RO7875913

  Up to approximately 3 months

• Part A: Observed Value of Pharmacodynamic Markers

  Baseline, up to approximately 3 months

• Part B: Serum Concentration of RO7875913

  Up to approximately 2 years

Study Arms (3)

Part A: RO7875913

EXPERIMENTAL

Participants will receive RO7875913.

Drug: RO7875913

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Drug: Placebo

Part B: RO7875913 with cevostamab

EXPERIMENTAL

Participants will recieve RO7875913 with cevostamab.

Drug: RO7875913; Drug: Cevostamab

Interventions

Placebo DRUG

Participants will receive placebo as per the schedule described in the protocol.

Part A: Placebo

RO7875913 DRUG

Participants will receive RO7875913 as per the schedule described in the protocol.

Part A: RO7875913; Part B: RO7875913 with cevostamab

Cevostamab DRUG

Participants will receive cevostamab as per the schedule described in the protocol

Part B: RO7875913 with cevostamab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

New Zealand Clinical Research - Christchurch

Christchurch, Canterbury, 8011, New Zealand

Location

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part B is open label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): June 17, 2030
• Study Completion (Estimated): June 17, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)