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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-085 | Drug | HL-085 ( Capsule) is one MEK inhibitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted. | up to 12 mouths |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Ma, Bachelor | Contact | 86 13810268600 | maj@kechowpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongqi Tian, Ph.D | Shanghai Kechow Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38867257 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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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.
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| Vemurafenib |
| Drug |
Vemurafenib ( Tablet) is BRAF inhibitor, |
|
|
| Beijing Oncology Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Henan Province Oncology Hospital | Recruiting | Zhengzhou | Henan | China |
| First Affiliated Hospital, Medicine School of Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
| Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |