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

Genentech

Status and phase: Enrolling; Phase 1

Conditions: Locally Advanced Solid Tumors; Metastatic Solid Tumors; Recurrent Solid Tumors

Treatments: Drug: RO7566802; Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06031441

GO44431

2023-509266-38-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Cycle 1 Day 1, with certain exceptions
• Active hepatitis B or C
• Active tuberculosis
• Positive test for human immunodeficiency virus (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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Treatment:

Drug: Atezolizumab

Drug: RO7566802

Dose Expansion Cohort

Experimental group

Description:

Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Treatment:

Drug: Atezolizumab

Drug: RO7566802