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RecruitingLast updated: 3 November 2023

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

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 patients with locally advanced, recurrent, or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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 gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

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