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Clinical Trials in the USA / NCT06031441
Active, not recruiting Phase 1

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

NCT06031441 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 1
Started
2023-11-27
Last updated
2026-07-28

Condition(s) studied

Locally Advanced Solid TumorsRecurrent Solid TumorsMetastatic Solid Tumors

Investigational drug(s) / intervention(s)

RO7566802Atezolizumab

RO7566802: RO7566802 solution for infusion will be administered as specified in each treatment arm.

Atezolizumab: Atezolizumab solution for infusion will be administered as specified in each treatment arm.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Birmingham Alabama
Yale Cancer Center New Haven Connecticut
Icahn School of Medicine at Mount Sinai (ISMMS) New York New York
The Ohio State University Columbus Ohio
Magee-Woman's Hospital Harrisburg Pennsylvania
SCRI Oncology Partners Nashville Tennessee
St Vincent's Hospital Sydney Darlinghurst New South Wales
Peter Maccallum Cancer Centre Melbourne Victoria
British Columbia Cancer Agency - 600 10th Ave W Vancouver British Columbia
Princess Margaret Cancer Centre Toronto Ontario
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

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Genentech, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06031441 on ClinicalTrials.gov ↗ ← All trials in the USA