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
A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Genentech, Inc.
250 participants
Nov 27, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
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Interventions
RO7566802 solution for infusion will be administered as specified in each treatment arm.
Atezolizumab solution for infusion will be administered as specified in each treatment arm.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT06031441