Clinical trial · Interventional
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor
NCT03781219CI-TRIAL-00066788unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HL-085 | Drug | Tunlametinib | ALIAS |
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HL-085 plus Vemurafenib
- description
- 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)
- interventionNames
- Drug: HL-085
- Drug: Vemurafenib
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- up to 12 mouths
- description
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDShi 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