A PHASE I/II DOSE-ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-7035 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED SOLID TUMORS WITH A KRAS G12D MUTATION
Trial Description
This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and
expansion study designed to evaluate the safety, pharmacokinetics, and preliminary
activity of GDC-7035 as a single agent and in combination with other anti-cancer
therapies in participants with advanced or metastatic solid tumors that harbor the KRAS
G12D mutation.
Eligibility Requirements
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