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

Launched by GENENTECH, INC. · Sep 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RO7566802, which is being tested alone and in combination with another drug called atezolizumab. The goal is to find out if these treatments are safe and effective for people with certain advanced types of cancer that cannot be cured by standard therapies. This is the first time this medication is being tested in humans, and the study will involve two stages: one where the dose is gradually increased to find the right amount, and another where more people will be treated with the selected dose.

To participate in this trial, individuals should be between the ages of 65 and 74 and must have a specific type of cancer that has not responded to previous treatments. They should be in relatively good health, with a life expectancy of at least three months, and have measurable disease according to certain criteria. Participants can expect to receive close monitoring during the trial, including tests to check how their body is responding to the treatment. It’s important to know that there are specific health conditions that may prevent someone from joining the trial, such as active infections or certain heart diseases.

Gender

ALL

Eligibility criteria

• 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 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.