Tarlox and Sotorasib in Patients With KRAS G12C Mutations

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05313009
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase IB dose expansion trial with safety lead-in evaluating the safety, clinical activity/efficacy of the combination of tarloxotinib and sotorasib in patients with KRAS G12C mutation who have progressed on any small molecule targeting KRAS G12C mutant Non-Small Cell lung cancer.

Key Dates

First listed
Apr 6, 2022
Start date
Mar 7, 2022
Status verified
Nov 2025
Primary completion
Jul 7, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
    SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
  • Experimental: STAGE 2: EFFICACY (n=12)
    EFFICACY (n=12)

Primary Outcome Measure

Objective Response [ Time Frame: There is no defined time frame for response assessment in the protocol. Presumably, patients are followed for response until the they stop taking study drug and/or have disease progression. The latest an assessment occurred for a patient was 40 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425-

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Lung cancer
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OncologyLung oncologyLung disease
By research site
Hollings Cancer Center at Medical University of South Carolina· Charleston, SC

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