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OpenTrials
Active, not recruiting

NCT Number: NCT07342114

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

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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7875913

Drug

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

Placebo

Drug

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

Cevostamab

Drug

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

Primary outcomes

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

    Time frame: Up to approximately 3 months

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

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Part A: Serum concentration of RO7875913

    Time frame: 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

    Time frame: Baseline, Up to Day 76

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

    Time frame: Up to approximately 3 months

  4. Part A: Observed Value of Pharmacodynamic Markers

    Time frame: Baseline, up to approximately 3 months

  5. Part B: Serum Concentration of RO7875913

    Time frame: Up to approximately 2 years

  6. Part B: Serum Concentration of Cevostamab

    Time frame: Up to approximately 2 years

  7. Part B: Objective Response Rate

    Time frame: Up to approximately 2 years

  8. Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)

    Time frame: Up to approximately 2 years

  9. Part B: Rate of Very Good Partial Response (VGPR) or Better

    Time frame: Up to approximately 2 years

  10. Part B: Duration of Response

    Time frame: Up to approximately 2 years

  11. Part B: Time to First Response

    Time frame: Up to approximately 2 years

  12. Part B: Time to Best Response

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 2 years

  15. Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 15, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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