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Recruitment on holdLast updated: 18 May 2026

This study is evaluating how safe and effective a new drug is when given alone, and in combination with immunotherapy in people with locally advanced, recurrent, or metastatic solid cancersA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

Participants will be enrolled in 2 stages: dose escalation and expansion.

In the dose escalation stage, participants in successive cohorts will receive escalating doses of the experimental drug (called RO7566802) as an intravenous (IV) infusion on Day 1 of each 21-day cycle, followed by RO7566802 in combination with immunotherapy (called atezolizumab) as an IV infusion on Day 1 of each 21-day cycle.

In the dose expansion stage, participants with select solid cancers will receive a recommended dose of RO7566802, as determined in the dose escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab as an IV infusion on Day 1 of eacy 21-day cycle.

 

Conditions

This trial is treating people with locally advanced, recurrent, or metastatic solid cancers

Eligibility

Inclusion

  • 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
  • Measurable disease per RECIST v1.1
  • Disease that has progressed after at least one available standard therapy, and for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate, or for which a clinical trial of an investigational agent is a recognized standard of care
  • Tumor specimen availability, for certain cohorts

Exclusion

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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On hold hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Genentech, Inc.

Scientific Title

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

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