Status:
RECRUITING
Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Lead Sponsor:
Shanghai Kechow Pharma, Inc.
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, open-label, Phase 3 study
Detailed Description
This is a multicenter, randomized, open-label, Phase 3 study to evaluate Tunlamatinib plus Vemurafenib versus Investigator's choice of Chemotherapy based treatment as controls in patients with BRAFV60...
Eligibility Criteria
Inclusion
- Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- Male or female patients with 18 to 70 years of age at time of informed consent;
- Histological or cytologically confirmed metastatic CRC
- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)
- Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central laboratory testing of BRAF mutation status.
- Progression of disease after 1 or more prior regimens in the metastatic setting
- At least 1 site of radiographically measurable disease by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
- Life expectancy ≥ 3 months;
- Can swallow the medicine,
- Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:
- Be willing and able to complete all the study procedures and follow-up examinations.
Exclusion
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06008119
Start Date
October 25 2023
End Date
December 24 2026
Last Update
September 18 2025
Active Locations (1)
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1
Beijing Oncology Hospital
Beijing, Beijing Municipality, China