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

NCT03781219 | Unknown Phase 1

• 1 other identifier: HL-085-102
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.

  up to 12 mouths

Study Arms (1)

HL-085 plus Vemurafenib

EXPERIMENTAL

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)

Drug: HL-085; Drug: Vemurafenib

Interventions

HL-085 DRUG

HL-085 ( Capsule) is one MEK inhibitor.

HL-085 plus Vemurafenib

Vemurafenib DRUG

Vemurafenib ( Tablet) is BRAF inhibitor,

Also known as: ZELBORAF

HL-085 plus Vemurafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Kechow Pharma, Inc.: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Oncology Hospital

Beijing, Beijing Municipality, China

RECRUITING

Henan Province Oncology Hospital

Zhengzhou, Henan, China

RECRUITING

First Affiliated Hospital, Medicine School of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• Shi Y, Han X, Zhao Q, Zheng Y, Chen J, Yu X, Fang J, Liu Y, Huang D, Liu T, Shen H, Luo S, Yu H, Cao Y, Zhang X, Hu P. Tunlametinib (HL-085) plus vemurafenib in patients with advanced BRAF V600-mutant solid tumors: an open-label, single-arm, multicenter, phase I study. Exp Hematol Oncol. 2024 Jun 12;13(1):60. doi: 10.1186/s40164-024-00528-0.

  PMID: 38867257 DERIVED

MeSH Terms

Interventions

Vemurafenib

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hongqi Tian, Ph.D

  Shanghai Kechow Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jin Ma, Bachelor

CONTACT

86 13810268600; maj@kechowpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: December 19, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (4)