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This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product-HYP-2090PTSA | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product: HYP-2090PTSA | Drug | Dosage form: Capsule. Strength: 2.5 mg, 5 mg and 10mg. Method of administration: Take orally on an empty stomach. Do not chew. Swallow the product with warm water. Dose Escalation Phase PK Lead-in Period (C0D1 only): Take once (QD dosing regimen only). Starting from C1D1, and in the Dose Expansion part, subjects will take the protocol-specified dose of HYP-2090PTSA orally in the morning on an empty stomach and one hour before the evening meal (evening dosing applies to BID regimen only), administered once to twice daily or two to three times per week. The administration dosages are: QD (once daily); BID (twice daily); TIW (on Days 1, 3, and 5 of each week); BIW (on Days 1 and 4 of each week). Avoid drinking water as much as possible within 1 hour before and after dosing (except for the water taken with the medication). Do not re-administer the dose if vomiting occurs after drug intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase-2 dose (RP2D) | RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data | Approximately 2 years |
| Number of participants with dose limiting toxicities | Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period | 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments | Approximately 2 years |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Chang | Contact | +86-028-86021875 | kai.chang4086@huiyupharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Cancer Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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ORR is defined as the proportion of participants with confirmed complete response or partial response |
| Approximately 2 years |
| Progression-free survival (PFS) | Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1 | Approximately 2 years |
| Hunan Provincial Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| The first Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| Shandong Provincial Cancer Hospital | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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