Clinical Trials /

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

NCT04449874

Description:

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.

Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: GO42144
  • SECONDARY ID: 2020-000084-22
  • NCT ID: NCT04449874

Conditions

  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
GDC-6036Dose-escalation (Stage I), Dose Expansion (Stage II)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose-escalation (Stage I), Dose Expansion (Stage II)ExperimentalParticipants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a safety threshold is observed. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
  • GDC-6036

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants With Adverse Events (AEs)
Time Frame:From baseline up until 28 days after the final dose
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Plasma Concentration of GDC-6036
Time Frame:From baseline up until 28 days after the final dose or at study treatment discontinuation visit
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame:Up to 42 months
Safety Issue:
Description:
Measure:Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame:Up to 42 months
Safety Issue:
Description:
Measure:Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame:Up to 42 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Genentech, Inc.

Trial Keywords

  • KRAS G12C
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • GDC-6036

Last Updated

June 24, 2020