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

NCT06488716 | Terminated Phase 1 FDA Drug

• 2 other identifiers: GO452962024-513391-17-00
• Study Type: interventional
• Target: 12
• Locations: 4 countries
• Sites: 11

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.

Conditions

Solid Tumour

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Maximum Serum Concentration (Cmax) of RO7759065

  Up to approximately 5 years

• Objective Response Rate (ORR)

  Up to Approximately 5 Years

• Duration of Response (DOR)

  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

Study Arms (4)

Phase Ia: Dose Escalation

EXPERIMENTAL

Drug: RO7759065

Phase Ia: Expansion

EXPERIMENTAL

Drug: RO7759065

Phase Ib: Dose Escalation

EXPERIMENTAL

Drug: RO7759065; Drug: Atezolizumab

Phase Ib: Expansion

EXPERIMENTAL

Drug: RO7759065; Drug: Atezolizumab

Interventions

RO7759065 DRUG

Specified dose on specified days

Phase Ia: Dose Escalation; Phase Ia: Expansion; Phase Ib: Dose Escalation; Phase Ib: Expansion

Atezolizumab DRUG

Specified dose on specified days

Phase Ib: Dose Escalation; Phase Ib: Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (11)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of Colorado

Aurora, Colorado, 80045-2517, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Tennesse Oncology - NASH - SCRI - PPDS

Chattanooga, Tennessee, 37404-1130, United States

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4R2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2MR, Canada

Location

Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine

Montreal, Quebec, H3T 1E2, Canada

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Clinica Universidad de Navarra-Madrid

Madrid, 28027, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

atezolizumab

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 5, 2024
• Study Start: December 16, 2024
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); CA (3); AU (1); US (4)