A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Launched by GENENTECH, INC. · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called RO7502175, both on its own and in combination with another medication called atezolizumab. The study is designed for adults who have locally advanced or metastatic solid tumors, which means their cancer has spread and is difficult to treat. This includes various types of cancers, such as lung cancer, melanoma, and breast cancer. The goal of the trial is to see how safe the treatment is, how the body processes it, and whether it can help shrink tumors.

To participate in the trial, individuals should be at least 18 years old and have a life expectancy of at least 12 weeks. They must have a confirmed diagnosis of a solid tumor that cannot be treated with standard therapies and should not have received any cancer treatments in the three weeks before joining the study. Participants can expect to be part of a phase 1 study, which means they will help researchers learn more about the treatment's safety and effectiveness. It's important to note that pregnant or breastfeeding individuals cannot participate, and those with certain infections or active diseases will be excluded.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Life expectancy at least 12 weeks
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
• • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
• • Tumor Specimen availability
• Exclusion Criteria:
• • Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
• • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
• • Active hepatitis B or C or tuberculosis
• • Positive test for human immunodeficiency virus (HIV) infection
• • Acute or chronic active Epstein-Barr virus (EBV) infection at screening
• • Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
• • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• • Active or history of autoimmune disease
• • Prior allogeneic stem cell or organ transplantation