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 C1D1, with certain exceptions
- Active hepatitis B or C
- Active tuberculosis
- Positive test for 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 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 39 months
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration Time Curve (AUC) of RO7566802 Up to approximately 39 months Maximum Serum Concentration (Cmax) of RO7566802 Up to approximately 39 months Minimum Serum Concentration (Cmin) of RO7566802 Up to approximately 39 months Total Clearance (CL) of RO7566802 Up to approximately 39 months Volume of Distribution at Steady State (Vss) of RO7566802 Up to approximately 39 months Serum Concentration of Atezolizumab Up to approximately 39 months Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to approximately 39 months Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802 From Baseline up to approximately 39 months
Trial Locations
- Locations (11)
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
The Royal Marsden hospital
🇬🇧Sutton, United Kingdom
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