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
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
240
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Lead sponsor
Genentech, Inc.
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Start date
2026-03-11
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Number of sites
1
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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).
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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
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-06-17
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First posted
2026-01-15
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Registry last updated
2026-09-30
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Primary completion date
2030-06-17
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Start date
2026-03-11
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Participants
240
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Participant count basis
Estimated
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Planned participants
240
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Genentech, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07342114
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ClinicalTrials.gov ID
NCT07342114
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Registry record
Open registry record
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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
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

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

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
clinicaltrials.gov

  • New Zealand Clinical Research - ChristchurchChristchurch, New Zealand
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-526130-15-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)