Part A: The purpose of Part A of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants. Part B: The purpose of Part B of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7875913 administered in combination with the T cell-engaging bispecific antibody (TCB) cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Participants will receive RO7875913 as per the schedule described in the protocol.
Participants will receive placebo as per the schedule described in the protocol.
Participants will receive cevostamab as per the schedule described in the protocol
New Zealand Clinical Research - Christchurch
Christchurch, Canterbury, New Zealand
Part A: Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 3 months
Part B: Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Part A: Serum concentration of RO7875913
Time frame: Up to Day 76
Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
Time frame: Baseline, Up to Day 76
Part A: Recommended Phase II Dose (RP2D) of RO7875913
Time frame: Up to approximately 3 months
Part A: Observed Value of Pharmacodynamic Markers
Time frame: Baseline, up to approximately 3 months
Part B: Serum Concentration of RO7875913
Time frame: Up to approximately 2 years
Part B: Serum Concentration of Cevostamab
Time frame: Up to approximately 2 years
Part B: Objective Response Rate
Time frame: Up to approximately 2 years
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
Time frame: Up to approximately 2 years
Part B: Rate of Very Good Partial Response (VGPR) or Better
Time frame: Up to approximately 2 years
Part B: Duration of Response
Time frame: Up to approximately 2 years
Part B: Time to First Response
Time frame: Up to approximately 2 years
Part B: Time to Best Response
Time frame: Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
Time frame: Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period
Time frame: Up to approximately 2 years
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
Time frame: Up to approximately 2 years
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