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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • RO7851624

    Drug

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

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: RO7851624Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Adverse Events (AEs)

Time frame
Up to approximately 2 years

Secondary outcomes

1

Serum Concentration of RO7851624

Time frame
Up to approximately 2 years
2

Objective Response Rate (ORR)

Time frame
Up to approximately 2 years
3

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

Time frame
Up to approximately 2 years
4

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

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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