Trial results for a Phase 1 study (NCT04642365) investigating the combination of atezolizumab and RO7296682 in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2025-05-21. The study evaluated the safety, tolerability, and preliminary anti-tumor activity of the combination across various dose cohorts, reporting adverse events and one dose-limiting toxicity, before its termination.
Background
The study investigated atezolizumab in combination with RO7296682 for the treatment of advanced solid tumors. This Phase 1 trial aimed to assess the safety, tolerability, and preliminary anti-tumor activity of this combination.
Trial design
The study (NCT04642365) was a Phase 1 trial designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of RO7296682 in combination with atezolizumab. The trial enrolled 49 participants with advanced solid tumors. The study was structured into different cohorts, each receiving varying doses of RO7296682 in combination with a fixed dose of atezolizumab 1200 mg.
Key results
The trial results focused on the safety and tolerability of the combination therapy. For Part 1 of the study, evaluating adverse events (AEs) across different dose cohorts of RO7296682 combined with atezolizumab 1200 mg:
- Cohort 1 (RO7296682 0.3 mg) reported 6 participants with AEs.
- Cohort 2 (RO7296682 1.5 mg) reported 6 participants with AEs.
- Cohorts 3 (RO7296682 9 mg), 4 (RO7296682 20 mg), 5 (RO7296682 40 mg), and 7 (RO7296682 160 mg) each reported 7 participants with AEs.
- Cohort 6 (RO7296682 80 mg) reported 5 participants with AEs.
For Part 2, Cohort 1 (RO7296682 70 mg + Atezolizumab 1200 mg) reported 3 participants with AEs.
Regarding dose-limiting toxicities (DLTs) in Part 1:
- Cohorts 1 (RO7296682 0.3 mg), 2 (RO7296682 1.5 mg), and 3 (RO7296682 9 mg) reported 0 participants with DLTs.
- Cohort 4 (RO7296682 20 mg) reported 1 participant with DLTs.
The overall status of the trial was reported as TERMINATED.
What this means
The results from this Phase 1 study provide initial safety and tolerability data for the combination of atezolizumab and RO7296682 in participants with advanced solid tumors. While adverse events were observed across all dose cohorts, only one dose-limiting toxicity was reported in one cohort. The trial's status as TERMINATED indicates that further development of this specific combination, at least as initially planned, has ceased. These findings are crucial for understanding the safety profile of this investigational combination and informing future research directions for solid tumors.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04642365, titled "A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors," were posted on 2025-05-21 on clinicaltrials.gov.