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

A Phase Ia/Ib, Open-Label, Multicenter 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

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumour
• Intervention / Treatment: Drug: RO7759065; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4R2
      • British Columbia Cancer Agency
  • Ontario
    • Toronto, Ontario, Canada, M5G 2MR
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine
• Spain
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra-Madrid
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045-2517
      • University of Colorado
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404-1130
      • Tennesse Oncology - NASH - SCRI - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase Ia: Dose Escalation	Drug: RO7759065; Specified dose on specified days
Experimental: Phase Ia: Expansion	Drug: RO7759065; Specified dose on specified days
Experimental: Phase Ib: Dose Escalation	Drug: RO7759065; Specified dose on specified days; Drug: Atezolizumab; Specified dose on specified days
Experimental: Phase Ib: Expansion	Drug: RO7759065; Specified dose on specified days; Drug: Atezolizumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Duration of Response (DOR)	Up to approximately 5 years
Progression Free Survival (PFS)	Up to approximately 5 years
Maximum Serum Concentration (Cmax) of RO7759065	Up to approximately 5 years
Objective Response Rate (ORR)	Up to Approximately 5 Years
Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; atezolizumab
• Other Study ID Numbers: GO45296; 2024-513391-17-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No