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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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®

Recruiting Locations

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

Yale Cancer Center
New Haven, Connecticut 06520

Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York 10029

The Ohio State University
Columbus, Ohio 43221-3502

Magee-Woman's Hospital
Harrisburg, Pennsylvania 17109

SCRI Oncology Partners
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GO44431 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.