A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
NCT ID: NCT03781219
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
45 participants
INTERVENTIONAL
2018-07-01
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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HL-085 plus 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)
HL-085
HL-085 ( Capsule) is one MEK inhibitor.
Vemurafenib
Vemurafenib ( Tablet) is BRAF inhibitor,
Interventions
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HL-085
HL-085 ( Capsule) is one MEK inhibitor.
Vemurafenib
Vemurafenib ( Tablet) is BRAF inhibitor,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Kechow Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hongqi Tian, Ph.D
Role: STUDY_DIRECTOR
Shanghai Kechow Pharma, Inc.
Locations
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Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing Oncology Hospital
Beijing, Beijing Municipality, China
Henan Province Oncology Hospital
Zhengzhou, Henan, China
First Affiliated Hospital, Medicine School of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yuankai Shi, M.D
Role: primary
References
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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.
Other Identifiers
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HL-085-102
Identifier Type: -
Identifier Source: org_study_id
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