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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: HL-085; Drug: Vemurafenib

• Registration Number: NCT03781219
• Lead Sponsor: Shanghai Kechow Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-01
• Study Start: 2018-07-01
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HL-085 plus Vemurafenib	HL-085	HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID)
HL-085 plus Vemurafenib	Vemurafenib	HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID)

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	up to 12 mouths	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.

Trial Locations

Locations (4)

First Affiliated Hospital, Medicine School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Henan Province Oncology Hospital; 🇨🇳 Zhengzhou, Henan, China

Beijing Oncology Hospital; 🇨🇳 Beijing, Beijing, China