Phase III Study of GDC-7035 Alone and With Other Cancer Treatments in Adults With Advanced Solid Tumors Having KRAS G12D Mutation

What this Trial Is About

Researchers are studying GDC-7035, a drug being tested alone and with other anti-cancer treatments in adults with advanced or metastatic solid tumors that have a KRAS G12D mutation. This Phase III trial aims to assess the safety, how the drug moves through the body, and its initial effects in this patient group. The study is open-label and conducted at multiple centers with dose escalation and expansion phases. Participants receive GDC-7035 either as a single agent or combined with other anti-cancer therapies. The study follows a dose-escalation approach where doses are increased to find safe and effective levels. Both treatment arms involve protocol-defined dosing of GDC-7035, given sequentially. The trial includes a dose expansion phase to further evaluate the drugs effects at selected doses. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities using standardized criteria over four years. Blood and plasma samples will be collected at specific times to analyze drug concentrations, including comparisons of dosing with or without food. Researchers will measure tumor response rates, duration of response, and progression-free survival. The total study period extends up to the primary completion date in May 2028, with ongoing safety and activity assessments.

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