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
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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TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2024-12-16
2025-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase Ia: Dose Escalation
RO7759065
Specified dose on specified days
Phase Ia: Expansion
RO7759065
Specified dose on specified days
Phase Ib: Dose Escalation
RO7759065
Specified dose on specified days
Atezolizumab
Specified dose on specified days
Phase Ib: Expansion
RO7759065
Specified dose on specified days
Atezolizumab
Specified dose on specified days
Interventions
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RO7759065
Specified dose on specified days
Atezolizumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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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
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
Countries
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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