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

NCT ID: NCT06031441

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Solid Tumors Recurrent Solid Tumors Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Cohort

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.

Group Type EXPERIMENTAL

RO7566802

Intervention Type DRUG

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

Atezolizumab

Intervention Type DRUG

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

Dose Expansion Cohort

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.

Group Type EXPERIMENTAL

RO7566802

Intervention Type DRUG

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

Atezolizumab

Intervention Type DRUG

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

Interventions

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RO7566802

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

Intervention Type DRUG

Atezolizumab

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

Intervention Type DRUG

Other Intervention Names

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Tecentriq®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States

Site Status RECRUITING

Ohio University College of Osteopathic Medicine

Athens, Ohio, United States

Site Status RECRUITING

Magee-Woman's Hospital

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

British Columbia Cancer Agency - 600 10th Ave W

Vancouver, British Columbia, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status RECRUITING

St Bartholomew's Hospital

London, , United Kingdom

Site Status RECRUITING

Sarah Cannon Research Institute

London, , United Kingdom

Site Status RECRUITING

Churchill Hospital

Oxford, , United Kingdom

Site Status RECRUITING

The Royal Marsden hospital

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada Singapore United Kingdom

Central Contacts

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

Role: CONTACT

888-662-6728 (U.S. Only)

Other Identifiers

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2023-509266-38-00

Identifier Type: CTIS

Identifier Source: secondary_id

GO44431

Identifier Type: -

Identifier Source: org_study_id

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