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This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-085 | Experimental | HL-085 will be administered as BID with specified dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-085 | Drug | HL-085 is one MEK inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period | Duration of the study, estimated to be approximately 24 months. |
| Maximum tolerated dose (MTD) | The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT) | DLTs within the first cycle of therapy (up to 35 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as measure of efficacy | Efficacy estimated as the Objective Response Rate (ORR) , which is the sum of Partial Response (PR) and Complete Response (CR) as determined by RECIST 1.1 | Duration of the study, estimated to be approximately 24 months. |
| Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongqi Tian, Ph.D | Shanghai Kechow Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Fudan University Shanghai Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36600247 | Derived | Wang X, Luo Z, Chen J, Chen Y, Ji D, Fan L, Chen L, Zhao Q, Hu P, Sun P, Jia Z, Guo J, Si L. First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. BMC Med. 2023 Jan 4;21(1):2. doi: 10.1186/s12916-022-02669-7. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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AUC of HL-085 following single and repeated dosing |
| Duration of the study, estimated to be approximately 24 months |
| Peak Plasma Concentration (Cmax) | Cmax of HL-085 following single and repeated dosing | Duration of the study, estimated to be approximately 24 months |
| Time to maximum observed plasma drug concentration (Tmax) | Tmax of HL-085 following single and repeated dosing | Duration of the study, estimated to be approximately 24 months. |
| Half-life (T1/2) | T1/2 of HL-085 following single and repeated dosing | Duration of the study, estimated to be approximately 24 months. |
| Shanghai |
| Shanghai Municipality |
| China |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |