A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

ID#: NCT06031441

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: November 27, 2023

End Date: December 31, 2026

Contact Information:
Reference Study ID Number
888-662-6728 (U.S. Only)
Summary: This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
Eligibility:

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Life expectancy >=3 months, in the investigator's judgment

- Adequate hematologic and end-organ function

- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care

- Measurable disease per RECIST v1.1

- Tumor specimen availability, for certain cohorts

Exclusion Criteria:

- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions

- Active hepatitis B or C

- Active tuberculosis

- Positive test for HIV infection

- Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion

- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

- Active or history of autoimmune disease

- Prior allogeneic stem cell or organ transplantation

- Uncontrolled tumor-related pain

- Significant cardiovascular disease Other protocol-defined inclusion/exclusion criteria may apply.