A Study to Evaluate RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

May 6, 2026 updated by: Genentech, Inc.

An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma

This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors [PIs], immunomodulators [IMiDs], and anti-cluster of differentiation 38 [anti-CD38] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.
  • Measurable disease.

Exclusion Criteria:

  • Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.
  • Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.
  • Prior allogeneic SCT.
  • Prior solid organ transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RO7851624
Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage.
Drug: RO7851624
Participants will receive RO7851624 as per the schedule described in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Serum Concentration of RO7851624
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Rate of Very Good Partial Response (VGPR) Rate or Better
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to First Response
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Time to Best Response
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7851624 at Baseline and During the Study
Time Frame: Baseline, up to approximately 2 years
Baseline, up to approximately 2 years
Recommended Dose and Regimen of RO7851624
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO46140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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