Status:
TERMINATED
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicit...
Eligibility Criteria
Inclusion
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and end-organ function
- Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Availability of representative tumor specimens required for patients in select cohorts.
Exclusion
- Women who are pregnant or breastfeeding
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- Active hepatitis B or C or tuberculosis
- Positive test for human immunodeficiency virus (HIV) infection
- Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion
- Primary, untreated, or active central nervous system (CNS) metastases
- Active or history of autoimmune disease or immune deficiency
- Prior allogeneic stem cell or organ transplantation
- Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent
- Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.
Key Trial Info
Start Date :
December 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06488716
Start Date
December 16 2024
End Date
November 5 2025
Last Update
December 24 2025
Active Locations (11)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of Colorado
Aurora, Colorado, United States, 80045-2517
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
4
Tennesse Oncology - NASH - SCRI - PPDS
Chattanooga, Tennessee, United States, 37404-1130