Clinical trial · Interventional
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO7567132 and Atezolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part I: RO7567132 Dose Escalation With or Without Atezolizumab
- interventionNames
- Drug: RO7567132 and Atezolizumab
- type
- EXPERIMENTAL
- label
- Part II: RO7567132 Backfill With Atezolizumab
- interventionNames
- Drug: RO7567132 and Atezolizumab
Primary outcomes (2)
- measure
- Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
- timeFrame
- Up to a maximum of 27 months
- measure
- Percentage of Participants With Dose-limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants aged ≥18 years * Body weight \> 40 kilograms (kg) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks * Participants with advanced and/or metastatic solid tumors * Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy * Negative serum pregnancy test * Participants must have adequate cardiovascular, hematological, liver and renal function. Exclusion Criteria: * Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases * Active second malignancy within 2 years prior to screening * History or current clinically significant cardiovascular/cerebrovascular disease * Active or history of autoimmune disease * Serious, uncontrolled infection * Known clinically significant liver disease * Unresolved acute toxicity \> grade 1 from prior therapy
References
Publications (0)
Data not yet available