Solid Tumor
Conditions
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.
Interventions
DRUGHL-085
HL-085 ( Capsule) is one MEK inhibitor.
DRUGVemurafenib
Vemurafenib ( Tablet) is BRAF inhibitor,
Sponsors
Shanghai Kechow Pharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
If no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. BRAF V600 mutation in solid tumor. 2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors. 3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. 4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment. 5. ECOG performance status of 0-1. 6. Life expectancy ≥ 3 months. 7. Ability to take the medicine orally. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Hypersensitivity to study drug ingredients or their analogues. 2. Prior therapy with MEK-inhibitor. 3. Receiving any other anti-cancer therapy at the same time . 4. Active central nervous system (CNS) lesion. 5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment. 6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome； 7. Uncontrolled concomitant diseases or infectious diseases. 8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.). 9. History of HIV,HCV,HBV infection. 10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded. 11. Serum HCG test is positive. 12. Other conditions that increase the risk of study and influence the result.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | up to 12 mouths | Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted. |
Countries
China
Contacts
Primary ContactJin Ma, Bachelor
Outcome results
None listed