Official TitleA 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
Study 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 Criteria
Gender
All
Age
≥18 Years
Healthy Volunteers
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
Explore related studies
What is Clinical Research?
In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.
For the latest version of this information please go to www.forpatients.roche.com