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
- Conditions
- Locally Advanced Solid TumorsRecurrent Solid TumorsMetastatic Solid Tumors
- Interventions
- Registration Number
- NCT06031441
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- 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
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions
- 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
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort RO7566802 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. Dose Escalation Cohort Atezolizumab 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. Dose Expansion Cohort Atezolizumab 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. Dose Expansion Cohort RO7566802 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose-limiting Toxicity (DLTs) Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days) Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration Time Curve (AUC) of RO7566802 Up to approximately 4 years Maximum Serum Concentration (Cmax) of RO7566802 Up to approximately 4 years Volume of Distribution at Steady State (Vss) of RO7566802 Up to approximately 4 years Minimum Serum Concentration (Cmin) of RO7566802 Up to approximately 4 years Serum Concentration of Atezolizumab Up to approximately 4 years Total Clearance (CL) of RO7566802 Up to approximately 4 years Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to approximately 4 years Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802 From Baseline up to approximately 4 years
Trial Locations
- Locations (11)
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
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
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
St Bartholomew's Hospital
🇬🇧London, United Kingdom
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