This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Timeframe: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21
MTD/Recommended Phase 2 Dose (RP2D) of Autogene Cevumeran
Timeframe: Phase 1a: Days 1 to 14 / Phase 1b: Days 1 to 21
Percentage of Participants with Adverse Events (AEs)
Timeframe: Baseline up to end of the study (up to approximately 3 years)
Percentage of Participants with Immune-Mediated Adverse Events (imAEs)
Timeframe: Baseline up to end of the study (up to approximately 3 years)
Percentage of Participants by Number of Treatment Cycles Received
Timeframe: Baseline up to end of the study (up to approximately 3 years)
Dose Intensity of Autogene Cevumeran
Timeframe: Baseline up to end of the study (up to approximately 3 years)
Change from Baseline in Targeted Vital Signs
Timeframe: Baseline up to end of study (up to approximately 3 years)
Change from Baseline in Targeted Clinical Laboratory Test Results
Timeframe: Baseline up to end of study (up to approximately 3 years)
Change from Baseline in ECGs
Timeframe: Baseline up to end of study (up to approximately 3 years)