A Study to Evaluate the Safety and Pharmacokinetics of RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT07558915 | Not Yet Recruiting Phase 1

• 1 other identifier: GO46140
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  Up to approximately 2 years

Secondary Outcomes (10)

• Serum Concentration of RO7851624

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)

  Up to approximately 2 years

• Rate of Very Good Partial Response (VGPR) Rate or Better

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

Study Arms (1)

RO7851624

EXPERIMENTAL

Participants will receive RO7851624 in a dose escalation stage followed by a dose expansion stage.

Drug: RO7851624

Interventions

RO7851624 DRUG

Participants will receive RO7851624 as per the schedule described in the protocol.

RO7851624

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO46140 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share