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ACTIVE NOT RECRUITINGPhase1

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

Sponsor: Genentech, Inc.

NCT ID: NCT06031441

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RO7566802 (drug), Atezolizumab (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
RO7566802 — drug: RO7566802 solution for infusion will be administered as specified in each treatment arm. · Atezolizumab — drug: Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
65
Started
2023-11-27
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for locally advanced solid tumors
  • • Phase1 - 65 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with locally advanced solid tumors

Where?

  • • Cambridge - Addenbrooke's Hospital
  • • Leicester - Leicester Royal Infirmary
  • • London - St Bartholomew's Hospital
  • • London - Sarah Cannon Research Institute
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Locally Advanced Solid TumorsRecurrent Solid TumorsMetastatic Solid Tumors

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓activity scale (ECOG) Performance Status of 0-1
  • ✓Life expectancy \>=3 months, in the investigator's judgment
  • ✓Adequate blood and end-organ health
  • ✓cancer that can be measured on scans v1.1
  • ✓Tumor specimen availability, for certain cohorts

Who cannot take part

  • ✗Any anti-cancer therapy, whether investigational or approved, including drug treatment, hormonal therapy, or...
  • ✗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
See the full criteria
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.

Where Is This Study? (6 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Churchill Hospital

Oxford OX3 7LJ, United Kingdom

The Royal Marsden hospital

Sutton SM2 5PT, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416
Data sourced from ClinicalTrials.gov · Last verified: 2026-07