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

A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Solid Tumors; Metastatic Solid Tumors; Recurrent Solid Tumors
• Intervention / Treatment: Drug: RO7566802; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital Sydney
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • British Columbia Cancer Agency - 600 10th Ave W
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Recruiting
      • Princess Margaret Cancer Centre
• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Centre
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrooke's Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • Leicester Royal Infirmary
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St Bartholomew'S Hospital
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute
  • Oxford, United Kingdom, OX3 7LJ
    • Recruiting
    • Churchill Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Recruiting
    • The Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham (UAB)
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Cancer Center
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai (ISMMS)
  • Ohio
    • Columbus, Ohio, United States, 43221-3502
      • Recruiting
      • The Ohio State University
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • Recruiting
      • Magee-Woman's Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: RO7566802; RO7566802 solution for infusion will be administered as specified in each treatment arm.; Drug: Atezolizumab; Atezolizumab solution for infusion will be administered as specified in each treatment arm.; Other Names: Tecentriq®
Experimental: 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.	Drug: RO7566802; RO7566802 solution for infusion will be administered as specified in each treatment arm.; Drug: Atezolizumab; Atezolizumab solution for infusion will be administered as specified in each treatment arm.; Other Names: Tecentriq®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Serum Concentration of Atezolizumab	Up to approximately 4 years
Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Up to approximately 4 years
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802	From Baseline up to approximately 4 years

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; atezolizumab
• Other Study ID Numbers: GO44431; 2023-509266-38-00 (Ctis: EU Clinical Trials Information System (CTIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No