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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:07/15/2021

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.

  • Start Date10/22/2020
  • End Date08/31/2023

Trial Purpose and Description

Primary Outcome Measures  :

  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From baseline up until 28 days after the final dose ]
  2. Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Days 1-21 of Cycle 1 (a cycle is 21 days) ]
  3. Percentage of Participants With Changes From Baseline in Targeted Vital Signs [ Time Frame: From baseline up until 28 days after the final dose ]
  4. 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 ]
  5. 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

Sub-Investigators

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