Locally Advanced Solid Tumors, Metastatic Solid Tumors, Recurrent Solid Tumors
Conditions
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.
Interventions
DRUGRO7566802
RO7566802 solution for infusion will be administered as specified in each treatment arm.
DRUGAtezolizumab
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Minimum Serum Concentration (Cmin) of RO7566802 | Up to approximately 4 years |
| Total Clearance (CL) of RO7566802 | Up to approximately 4 years |
| Volume of Distribution at Steady State (Vss) of RO7566802 | Up to approximately 4 years |
| Serum Concentration of Atezolizumab | 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 |
Countries
Australia, Canada, Singapore, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed