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

Running, not enrolling · Phase 1

Conditions studied: Locally Advanced Solid Tumors, Recurrent Solid Tumors, Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT06031441

Run by

Genentech, Inc.

People needed

65

Starts

2023-11-27

Expected to finish

2027-03-03

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Icahn School of Medicine at Mount Sinai (ISMMS) — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Magee-Woman's Hospital — Harrisburg, Pennsylvania, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
• British Columbia Cancer Agency - 600 10th Ave W — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• National University Hospital — Singapore, Singapore
• National Cancer Centre — Singapore, Singapore
• Addenbrooke's Hospital — Cambridge, United Kingdom
• Leicester Royal Infirmary — Leicester, United Kingdom
• St Bartholomew's Hospital — London, United Kingdom
• Sarah Cannon Research Institute — London, United Kingdom
• Churchill Hospital — Oxford, United Kingdom
• The Royal Marsden hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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