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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Locally Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB), Birmingham, Alabama, United States, 35233

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06520

New York

Icahn School of Medicine at Mount Sinai (ISMMS); The Derald H. Ruttenberg Treatment Center, New York, New York, United States, 10029

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
  • * Active hepatitis B or C
  • * Active tuberculosis
  • * Positive test for 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2026-12-31