A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Shanghai Kechow Pharma, Inc.1 site in 1 country165 target enrollmentOctober 25, 2023

ConditionsColorectal Cancer Metastatic

InterventionsTunlametinib plus Vemurafenib Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab

DrugsTunlametinib plus Vemurafenib Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab

Overview

Phase: Phase 3
Intervention: Tunlametinib plus Vemurafenib
Conditions: Colorectal Cancer Metastatic
Sponsor: Shanghai Kechow Pharma, Inc.
Enrollment: 165
Locations: 1
Primary Endpoint: Progression-free Survival (PFS)
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 BRAFV600E mutant Metastatic Colorectal Cancer (CRC) whose disease has progressed after 1 or more prior regimens in the metastatic setting.

Registry

clinicaltrials.gov

Start Date

October 25, 2023

End Date

December 24, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Kechow Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria:
•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;

Exclusion Criteria

•Exclusion Criteria:
•Prior treatment with any BRAF and MEK inhibitor;
•Known contraindication to receive the treatment of control arm (according to latest PI).
•Symptomatic brain metastasis or leptomeningeal disease
•History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
•Known history of acute or chronic pancreatitis
•Uncontrolled GI bleeding, Dysphagia，refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.
•Serious cardiovascular disease , including uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia , deep vein thrombosis or pulmonary emboli or cerebrovascular events ≤ 6 months prior to starting study treatment;
•History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
•Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)