A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor

Shanghai Kechow Pharma, Inc.4 sites in 1 country45 target enrollmentJuly 1, 2018

ConditionsSolid Tumor

InterventionsHL-085 Vemurafenib

DrugsHL-085 Vemurafenib

Overview

Phase: Phase 1
Intervention: HL-085
Conditions: Solid Tumor
Sponsor: Shanghai Kechow Pharma, Inc.
Enrollment: 45
Locations: 4
Primary Endpoint: Number of Adverse Events
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

December 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Kechow Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•BRAF V600 mutation in solid tumor.
•One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
•Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
•Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
•ECOG performance status of 0-
•Life expectancy ≥ 3 months.
•Ability to take the medicine orally.
•Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•Hypersensitivity to study drug ingredients or their analogues.
•Prior therapy with MEK-inhibitor.
•Receiving any other anti-cancer therapy at the same time .
•Active central nervous system (CNS) lesion.
•Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
•ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
•Uncontrolled concomitant diseases or infectious diseases.
•Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
•History of HIV,HCV,HBV infection.
•Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.