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
- Registration Number
- NCT06488716
- Lead Sponsor
- Genentech, Inc.
- 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, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 310
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase Ia: Dose Escalation RO7759065 - Phase Ib: Dose Escalation RO7759065 - Phase Ia: Expansion RO7759065 - Phase Ib: Dose Escalation Atezolizumab - Phase Ib: Expansion Atezolizumab - Phase Ib: Expansion RO7759065 -
- Primary Outcome Measures
Name Time Method Number of Participants iwth Dose Limiting Toxicity (DLTs) Up to approximately 5 years Number of Participants with Adverse Events (AEs) Up to approximately 5 years
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to Approximately 5 Years Duration of Response (DOR) Up to approximately 5 years Maximum Serum Concentration (Cmax) of RO7759065 Up to approximately 5 years Progression Free Survival (PFS) Up to approximately 5 years Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065 Up to approximately 5 years
Trial Locations
- Locations (8)
University of Colorado
🇺🇸Aurora, Colorado, United States
Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine
🇨🇦Montreal, Quebec, Canada
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Tennesse Oncology - NASH - SCRI - PPDS
🇺🇸Chattanooga, Tennessee, United States
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada