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Imatinib and Trametinib for KRAS-mutated Solid Tumor

NCT06962254 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-08

No results posted yet for this study

Summary

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

  • Solid Tumor Cancer

Interventions

DRUG

Imatinib

1. Imatinib is binding to the ATP-binding site of BCR-ABL, blocking its activity and preventing uncontrolled proliferation to target the BCR-ABL fusion protein in chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It also inhibits PDGFR and c-KIT receptors, suppressing tumor growth and angiogenesis in gastrointestinal stromal tumors (GIST). 2. Preclinical studies have shown that imatinib combined with MEK inhibitors can suppress the growth of KRAS-mutated pancreatic adenocarcinoma.

DRUG

Trametinib

Trametinib inhibits the MEK1 and MEK2 enzymes, preventing the downstream phosphorylation and activation of ERK1/2, which are crucial for the RAS-RAF-MEK-ERK signaling pathway. By blocking this pathway, trametinib reduces cell proliferation and induces apoptosis in tumor cells harboring pathway mutations.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-10
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Taiwan

Study Locations

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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 NCT06962254 on ClinicalTrials.gov