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

NCT ID: NCT06488716

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2025-11-05

Brief Summary

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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

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Conditions

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Solid Tumour

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ia: Dose Escalation

Group Type EXPERIMENTAL

RO7759065

Intervention Type DRUG

Specified dose on specified days

Phase Ia: Expansion

Group Type EXPERIMENTAL

RO7759065

Intervention Type DRUG

Specified dose on specified days

Phase Ib: Dose Escalation

Group Type EXPERIMENTAL

RO7759065

Intervention Type DRUG

Specified dose on specified days

Atezolizumab

Intervention Type DRUG

Specified dose on specified days

Phase Ib: Expansion

Group Type EXPERIMENTAL

RO7759065

Intervention Type DRUG

Specified dose on specified days

Atezolizumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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RO7759065

Specified dose on specified days

Intervention Type DRUG

Atezolizumab

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Tennesse Oncology - NASH - SCRI - PPDS

Chattanooga, Tennessee, United States

Site Status

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Clinica Universidad de Navarra-Madrid

Madrid, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Countries

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United States Australia Canada Spain

Other Identifiers

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2024-513391-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

GO45296

Identifier Type: -

Identifier Source: org_study_id