Status:
UNKNOWN
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
Lead Sponsor:
Shanghai Kechow Pharma, Inc.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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 0-1.
- Life expectancy ≥ 3 months.
- Ability to take the medicine orally.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 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.
- Serum HCG test is positive.
- Other conditions that increase the risk of study and influence the result.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03781219
Start Date
July 1 2018
End Date
December 1 2023
Last Update
May 31 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
2
Beijing Oncology Hospital
Beijing, Beijing Municipality, China
3
Henan Province Oncology Hospital
Zhengzhou, Henan, China
4
First Affiliated Hospital, Medicine School of Zhejiang University
Hangzhou, Zhejiang, China