Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06031441

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

Led by Genentech, Inc. · Updated on 2026-05-04

250

Participants Needed

18

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life expectancy of at least 3 months according to investigator judgment
  • Adequate blood counts and organ function
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that progressed after standard therapy, or if standard therapy is ineffective, intolerable, or inappropriate, or if clinical trial is standard care
  • Measurable disease based on RECIST v1.1 criteria
  • Availability of tumor specimen for certain cohorts
Not Eligible

You will not qualify if you...

  • Any anti-cancer therapy, investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks before starting treatment
  • Active hepatitis B or C infection
  • Active tuberculosis
  • Positive test for HIV infection
  • Received live, attenuated vaccine within 4 weeks before RO7566802 infusion
  • Symptomatic, untreated, or actively progressing central nervous system metastases
  • Active or history of autoimmune disease
  • Prior allogeneic stem cell or organ transplant
  • Uncontrolled tumor-related pain
  • Significant cardiovascular disease
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Yale Cancer Center

New Haven, Connecticut, United States, 06520

Actively Recruiting

3

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States, 10029

Actively Recruiting

4

The Ohio State University

Columbus, Ohio, United States, 43221-3502

Actively Recruiting

5

Magee-Woman's Hospital

Harrisburg, Pennsylvania, United States, 17109

Actively Recruiting

6

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

7

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

Actively Recruiting

8

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

9

British Columbia Cancer Agency - 600 10th Ave W

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

10

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 1Z5

Actively Recruiting

11

National University Hospital

Singapore, Singapore, 119074

Actively Recruiting

12

National Cancer Centre

Singapore, Singapore, 168583

Actively Recruiting

13

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

14

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Actively Recruiting

15

St Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Actively Recruiting

16

Sarah Cannon Research Institute

London, United Kingdom, W1G 6AD

Actively Recruiting

17

Churchill Hospital

Oxford, United Kingdom, OX3 7LJ

Actively Recruiting

18

The Royal Marsden hospital

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

R

Reference Study ID Number: GO44431 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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