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

Genentech

Status and phase: Not yet enrolling; Phase 1

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Drug: RO7851624

Study type: Interventional

Funder types: Industry

Identifiers

NCT07558915

GO46140

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

RO7851624

Experimental group

Description:

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

Treatment:

Drug: RO7851624