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This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10587 Monotherapy | Experimental | Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10587 | Drug | HS-10587 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLT | dose-limiting toxicities | Up to 21 days after the first administration. (first cycle) |
| MTD or MAD | maximum tolerated dose (MTD) or maximum applicable dose (MAD) | Up to 21 days after the first administration. (first cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Number of participants with AEs and SAEs | From time of informed consent to 28 days post last dose of HS-10587. |
| Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors |
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Inclusion Criteria:
Exclusion Criteria:
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Maximum concentration (Cmax). |
| Predose and postdose up to end of treatment, approximately 2 years |
| Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors | Time of maximum concentration (Tmax). | Predose and postdose up to end of treatment, approximately 2 years. |
| Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors | area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t) | Predose and postdose up to end of treatment, approximately 2 years. |
| Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors | Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) | Predose and postdose up to end of treatment, approximately 2 years |
| Efficacy of HS-10587 in patients with advanced solid tumors | Objective response rate (ORR) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years |
| Efficacy of HS-10587 in patients with advanced solid tumors. | Duration of response (DOR) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years. |
| Efficacy of HS-10587 in patients with advanced solid tumors. | Disease control rate (DCR) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years |
| Efficacy of HS-10587 in patients with advanced solid tumors. | Time to response (TTR) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years. |
| Efficacy of HS-10587 in patients with advanced solid tumors. | Progression-free survival (PFS) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years. |
| Efficacy of HS-10587 in patients with advanced solid tumors. | Overall survival (OS) evaluated as per RECIST v1.1 | Predose and post dose up to end of treatment, approximately 2 years |