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RecruitingInterventionalPhase 1

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

NCT ID: NCT06031441Sponsor: Genentech, Inc.Last updated: 2026-06-02

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.

Arms & 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.

Outcome measures

Primary

  • Number of Participants with Dose-limiting Toxicity (DLTs)

    Time frame: 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)

    Time frame: Up to approximately 4 years

Secondary

  • Area Under the Serum Concentration Time Curve (AUC) of RO7566802

    Time frame: Up to approximately 4 years

  • Maximum Serum Concentration (Cmax) of RO7566802

    Time frame: Up to approximately 4 years

  • Minimum Serum Concentration (Cmin) of RO7566802

    Time frame: Up to approximately 4 years

  • Total Clearance (CL) of RO7566802

    Time frame: Up to approximately 4 years

  • Volume of Distribution at Steady State (Vss) of RO7566802

    Time frame: Up to approximately 4 years

  • Serum Concentration of Atezolizumab

    Time frame: 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)

    Time frame: Up to approximately 4 years

  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802

    Time frame: From Baseline up to approximately 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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/exclusion criteria may apply.

Study locations (6)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06520

Recruiting

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029

Recruiting

The Ohio State University

Columbus, Ohio, 43221-3502

Recruiting

Magee-Woman's Hospital

Harrisburg, Pennsylvania, 17109

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
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 | Cancerify