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NCT05313009 · ClinicalTrials.gov registry record · Phase 1
Tarlox and Sotorasib in Patients With KRAS G12C Mutations
A Phase 1 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05313009: Clinical Trial Phase 1 study, sponsored by Medical University of South Carolina.
NCT05313009 is a Phase 1 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05313009, a Phase 1 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
(OR = CR+PR) measured by CT and assessed per RECIST 1.1. Complete response (CR) and partial response (PR) require confirmatory CT
Interventions
- DRUG Sotorasib and Tarloxotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
Why NCT05313009 stopped before completion
NCT05313009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Sotorasib and Tarloxotinib is the first listed.
NCT05313009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05313009 about?
NCT05313009 is a clinical study titled "Tarlox and Sotorasib in Patients With KRAS G12C Mutations". 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.
What is the current status of trial NCT05313009?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-03-07. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05313009?
The interventions under investigation include: Sotorasib and Tarloxotinib (DRUG).
Who is sponsoring clinical trial NCT05313009?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05313009's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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