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Healthy VolunteersPhase 1NCT07342114

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

A Phase 1 study testing RO7875913 and Cevostamab in people with Healthy Volunteers and Relapsed Multiple Myeloma, run by Genentech, Inc. at 1 site in New Zealand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
RO7875913 and Cevostamab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteNew Zealand
Study dates
11 Mar 2026to 17 Jun 2030
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • New Zealand Clinical Research - Christchurch

    Christchurch, Canterbury, 8011

Other trials in New Zealand

About this study

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

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).

Being tested
RO7875913, Placebo, Cevostamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7875913Drug

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

  • PlaceboDrug

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

  • CevostamabDrug

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

Study groups in NCT07342114
Study groupRoleWhat they receive
Part A: RO7875913ExperimentalParticipants will receive RO7875913.
Receives: Drug: RO7875913
Part A: PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo
Part B: RO7875913 with cevostamabExperimentalParticipants will recieve RO7875913 with cevostamab.
Receives: Drug: RO7875913; Drug: Cevostamab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to approximately 3 months

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

    Measured: Up to approximately 2 years

Secondary outcomes (15)

  1. Part A: Serum concentration of RO7875913

    Measured: 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

    Measured: Baseline, Up to Day 76

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

    Measured: Up to approximately 3 months

  4. Part A: Observed Value of Pharmacodynamic Markers

    Measured: Baseline, up to approximately 3 months

  5. Part B: Serum Concentration of RO7875913

    Measured: Up to approximately 2 years

  6. Part B: Serum Concentration of Cevostamab

    Measured: Up to approximately 2 years

  7. Part B: Objective Response Rate

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 2 years

  10. Part B: Duration of Response

    Measured: Up to approximately 2 years

  11. Part B: Time to First Response

    Measured: Up to approximately 2 years

  12. Part B: Time to Best Response

    Measured: 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

    Measured: 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

    Measured: Up to approximately 2 years

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

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start11 Mar 2026
  3. Primary completion17 Jun 2030 (estimated)
  4. Study completion17 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07342114
Sponsor's protocol ID
GO46451
Other IDs
2026-526130-15-00
Status last verified
Sep 2026
First submitted
6 Jan 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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