Status:
RECRUITING
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Locally Advanced Solid Tumors
Recurrent Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06031441
Start Date
November 27 2023
End Date
December 31 2027
Last Update
January 9 2026
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
3
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States, 10029
4
Ohio University College of Osteopathic Medicine
Athens, Ohio, United States, 45701