A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

• Status: Recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Kechow Pharma, Inc.
• Treatments: Vemurafenib

Criteria

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.