A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
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
Genentech, Inc.
410 participants
Nov 14, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria2
- 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 Criteria3
- Malabsorption or other condition that would interfere with enteral absorption
- Active brain metastases
- Clinically significant cardiovascular dysfunction or liver disease
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Interventions
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
Locations(36)
View Full Details on ClinicalTrials.gov
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NCT06619587