A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

Roche

Status and phase

Active, not recruiting

Phase 1

Conditions

Cancer-Neoplasms

Treatments

Drug: RO7567132 and Atezolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06537310

BP44956

2024-512839-70-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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