For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  2. Life expectancy >=3 months, in the investigator's judgment
  3. Adequate hematologic and end-organ function
  4. 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
  5. Measurable disease per RECIST v1.1
  6. Tumor specimen availability, for certain cohorts

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
  2. Active hepatitis B or C
  3. Active tuberculosis
  4. Positive test for HIV infection
  5. Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
  6. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  7. Active or history of autoimmune disease
  8. Prior allogeneic stem cell or organ transplantation
  9. Uncontrolled tumor-related pain
  10. Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-662-6728 (U.S. Only)Email iconEmail Study Center

Study Details


Contition

Locally Advanced Solid Tumors,Recurrent Solid Tumors,Metastatic Solid Tumors

Age

18+

Phase

PHASE1

Participants Needed

250

Est. Completion Date

Dec 31, 2026

Treatment Type

INTERVENTIONAL


Sponsor

Genentech, Inc.

ClinicalTrials.gov NCT Identifier

NCT06031441

Study Number

GO44431

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