A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT06537310
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Cancer-Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RO7567132 and Atezolizumab — DRUGRO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
- RO7567132 and Atezolizumab — DRUGRO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Study Details
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.
Key Dates
- Start date
- Sep 16, 2024
- Status verified
- May 2026
- Primary completion
- May 12, 2027
- Completion
- Aug 10, 2027
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part I: RO7567132 Dose Escalation With or Without Atezolizumab
- Experimental: Part II: RO7567132 Backfill With Atezolizumab
Primary Outcome Measure
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) [ Time Frame: Up to a maximum of 27 months ]