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RO7875913

Phase 1

Relapsed Multiple Myeloma | Small molecule | Other |Roche Holding AG|Trials Updated: Sep 30, 2026

RO7875913 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

RO7875913 clinical trials

RO7875913 · 1 trial · 3 indications

Phase 1 1
NCT07342114A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple MyelomaHealthy Volunteers
ACTIVE NOT_RECRUITING240 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: RO7875913EXPERIMENTALParticipants will receive RO7875913.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive placebo.
Part B: RO7875913 with cevostamabEXPERIMENTALParticipants will recieve RO7875913 with cevostamab.

Interventions

NameTypeDescription
RO7875913DRUGParticipants will receive RO7875913 as per the schedule described in the protocol.
PlaceboDRUGParticipants will receive placebo as per the schedule described in the protocol.
CevostamabDRUGParticipants will receive cevostamab as per the schedule described in the protocol
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:New Zealand
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Competitive Landscape -Multiple Myeloma 338 trials (matched to "Relapsed Multiple Myeloma")

Recent Changes (Last 90 Days)

LOWSep 30, 2026NCT07342114lastUpdatePostDate: changed
LOWSep 30, 2026NCT07342114lastUpdatePostDate: changed
MEDIUMSep 11, 2026NCT07342114Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 11, 2026NCT07342114Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about RO7875913

What is RO7875913?

RO7875913 is an investigational small molecule being developed by Roche Holding AG for relapsed multiple myeloma. It is in Phase 1 clinical development and is also being studied in healthy participants. It has not been approved by the FDA and remains an experimental therapy under clinical evaluation.

What is RO7875913 used for in relapsed multiple myeloma?

RO7875913 is being studied for relapsed and refractory multiple myeloma, a blood cancer that has returned or stopped responding to prior treatment. The Phase 1 program evaluates RO7875913 both alone in healthy participants and in combination with cevostamab in participants with relapsed or refractory multiple myeloma.

Who makes RO7875913?

RO7875913 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor running the clinical program for this investigational small molecule in relapsed multiple myeloma and in healthy volunteer studies.

What phase is RO7875913 in?

RO7875913 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes one active trial that is no longer recruiting participants, with a planned enrollment of 240 people.

What clinical trials is RO7875913 in?

RO7875913 is being evaluated in the Phase 1 trial NCT07342114, titled a study of the effects of RO7875913 in healthy participants and of RO7875913 with cevostamab in participants with relapsed or refractory multiple myeloma. The trial is active but not recruiting, is placebo controlled and double blind, and enrolls 240 participants in New Zealand.

Is RO7875913 combined with cevostamab in its trial?

Yes. The Phase 1 trial NCT07342114 evaluates RO7875913 in combination with cevostamab in participants with relapsed or refractory multiple myeloma, while also assessing RO7875913 alone in healthy participants. The study is placebo controlled, double blind, randomized, and is being conducted in New Zealand.