Phase I
A Phase I Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
- Study HIC#:2000028685
- Last Updated:08/06/2024
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
Primary Outcome Measures :
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Days 1-21 of Cycle 1 (a cycle is 21 days) ]
- Percentage of Participants With Changes From Baseline in Targeted Vital Signs [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline up until 28 days after the final dose ]
- Percentage of Participants With Changes From Baseline in Targeted ECG Parameters [ Time Frame: From baseline up until 28 days after the final dose ]
Eligibility Criteria
Inclusion Criteria:
- Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
Exclusion Criteria:
- Active brain metastases
- Malabsorption or other condition that interferes with enteral absorption
- Clinically significant cardiovascular dysfunction or liver disease
