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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Participants will receive RO7851624 as per the schedule described in the protocol.
Peter MacCallum Cancer Center
Parkville, Victoria, Australia
RECRUITINGPercentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years
Serum Concentration of RO7851624
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Complete Response (CR) Rate/ Stringent Complete Response (sCR) Rate)
Time frame: Up to approximately 2 years
Rate of Very Good Partial Response (VGPR) Rate or Better
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to First Response
Time frame: Up to approximately 2 years
Time to Best Response
Time frame: 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
Recommended Dose and Regimen of RO7851624
Time frame: Up to approximately 2 years
Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below.
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