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Tarlox and Sotorasib in Patients With KRAS G12C Mutations

NCT05313009 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-12-16

Study results available
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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.

Conditions

Interventions

DRUG

Sotorasib and Tarloxotinib

Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly

DRUG

Sotorasib and Tarloxotinib

Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).

Sponsors & Collaborators

  • Rain Oncology Inc

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2023-07-07
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313009 on ClinicalTrials.gov