A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

Launched by GENENTECH, INC. · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called GDC-7035 for patients with advanced solid tumors that have a specific genetic mutation known as KRAS G12D. The study aims to find out how safe this treatment is, how it behaves in the body, and whether it can help shrink the tumors when used alone or alongside other cancer treatments. It is currently open for enrollment and is accepting both men and women aged 65 to 74 who have been diagnosed with this type of cancer.

To participate, patients need to have a confirmed diagnosis of an advanced solid tumor with the KRAS G12D mutation and must agree to follow certain guidelines regarding contraception if applicable. However, individuals with conditions like severe liver disease, ongoing brain metastases (cancer spread to the brain), or issues that affect how the body absorbs medications won’t be eligible. Participants can expect close monitoring throughout the study to ensure their safety and to assess how well the treatment is working.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
• • Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
• Exclusion criteria:
• • Malabsorption or other condition that would interfere with enteral absorption
• • Active brain metastases
• • Clinically significant cardiovascular dysfunction or liver disease