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 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: GO444312023-509266-38-00
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

Locally Advanced Solid Tumors; Recurrent Solid Tumors; Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose-limiting Toxicity (DLTs)

  Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)

• Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

  Up to approximately 4 years

Secondary Outcomes (8)

• Area Under the Serum Concentration Time Curve (AUC) of RO7566802

  Up to approximately 4 years

• Maximum Serum Concentration (Cmax) of RO7566802

  Up to approximately 4 years

• Minimum Serum Concentration (Cmin) of RO7566802

  Up to approximately 4 years

• Total Clearance (CL) of RO7566802

  Up to approximately 4 years

• Volume of Distribution at Steady State (Vss) of RO7566802

  Up to approximately 4 years

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

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.

Drug: RO7566802; Drug: Atezolizumab

Dose Expansion Cohort

EXPERIMENTAL

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.

Drug: RO7566802; Drug: Atezolizumab

Interventions

RO7566802 DRUG

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

Dose Escalation Cohort; Dose Expansion Cohort

Atezolizumab DRUG

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

Also known as: Tecentriq®

Dose Escalation Cohort; Dose Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (18)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43221-3502, United States

RECRUITING

Magee-Woman's Hospital

Harrisburg, Pennsylvania, 17109, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

British Columbia Cancer Agency - 600 10th Ave W

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

National Cancer Centre

Singapore, 168583, Singapore

RECRUITING

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

RECRUITING

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

RECRUITING

The Royal Marsden hospital

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Interventions

atezolizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GB (6); SG (2); US (6); CA (2)