A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06031441
Last Updated: 2026-01-09
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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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2023-11-27
2027-12-31
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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Dose Escalation Cohort
Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Dose Expansion Cohort
Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Interventions
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RO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy \>=3 months, in the investigator's judgment
* Adequate hematologic and end-organ function
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
* Measurable disease per RECIST v1.1
* Tumor specimen availability, for certain cohorts
Exclusion Criteria
* Active hepatitis B or C
* Active tuberculosis
* Positive test for human immunodeficiency virus (HIV) infection
* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation
* Uncontrolled tumor-related pain
* Significant cardiovascular disease
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
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Yale Cancer Center
New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States
Ohio University College of Osteopathic Medicine
Athens, Ohio, United States
Magee-Woman's Hospital
Harrisburg, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
British Columbia Cancer Agency - 600 10th Ave W
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
National Cancer Centre
Singapore, , Singapore
Addenbrooke's Hospital
Cambridge, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
The Royal Marsden hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: GO44431 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2023-509266-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
GO44431
Identifier Type: -
Identifier Source: org_study_id
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