Actively Recruiting

Phase 1
Age: 20Years +
All Genders
NCT06962254

Imatinib and Trametinib for KRAS-mutated Solid Tumor

Led by China Medical University Hospital · Updated on 2025-05-08

10

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this pilot trial, participants with unresectable solid cancers harboring KRAS mutations will be provided with a compassionate treatment if their diseases progress after current standard treatments, or there is no available standard treatment. This trial will evaluate the efficacy and safety of the combination of trametinib and imatinib on chemotherapy refractory solid cancers.

CONDITIONS

Official Title

Imatinib and Trametinib for KRAS-mutated Solid Tumor

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Histologically confirmed locally advanced or metastatic solid tumors with KRAS G12X mutation
  • Disease progression during or within 6 months after standard chemotherapy or no available standard therapy
  • Measurable disease according to RECIST v1.1 criteria
  • ECOG Performance Status of 0 to 2
  • Life expectancy of at least 8 weeks
  • Adequate blood counts: white blood cells 63,000/ul, absolute neutrophil count 61,500/ul, hemoglobin 69 g/dl, platelet count 60,000/ul
  • Adequate liver function: ALT and AST 62.5 times upper limit of normal, or 65.0 times if due to liver metastases; total bilirubin 61.5 times upper limit, or 63.0 if due to liver metastases
  • Adequate kidney function: serum creatinine 62 times upper limit of normal or creatinine clearance 630 ml/min
  • Adequate blood clotting function with PT INR 62.3
  • Normal or clinically acceptable ECG
  • Ability to understand and sign informed consent
  • Agreement to use effective contraception if of reproductive potential
Not Eligible

You will not qualify if you...

  • History of allergic reaction to trametinib or imatinib
  • Previous exposure to KRAS G12C inhibitors
  • Current or prior use of kinase inhibitors
  • Major abdominal surgery, radiotherapy, or investigational agents within 2 weeks (except palliative radiotherapy not involving the only lesion of measurable disease)
  • Liver cirrhosis with Child-Pugh score 8 or higher
  • Uncorrected electrolyte abnormalities
  • Metastatic lesions in the central nervous system
  • Active infection
  • Incomplete recovery from toxicity of prior cancer treatments or major surgery
  • Serious systemic disorders incompatible with study participation
  • Other prior or concurrent malignancies except certain treated carcinomas or those disease-free for 3 years
  • Pregnant or breastfeeding women
  • Psychiatric illness interfering with study compliance
  • Use of strong CYP450 enzyme inducers or inhibitors, or other unapproved drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China Medical University Hospital

Taichung, Taichung, Taiwan, 404

Actively Recruiting

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Research Team

L

Li-Yuan Bai

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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