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

Stopped early · Phase 1

Conditions studied: Solid Tumour

In brief

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.

Key facts

Study ID

NCT06488716

Run by

Genentech, Inc.

People needed

12

Starts

2024-12-16

Expected to finish

2025-11-05

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• University of Colorado — Aurora, Colorado, 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
• Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine — Montreal, Quebec, Canada
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Clinica Universidad de Navarra-Madrid — Madrid, Spain
• Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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