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This is a first-in-human study with the SYHX2005 tablet primarily designed to evaluate the safety and tolerability of SYHX2005 at increasing doses in patients with advanced solid tumors and for whom no standard of care exists. The study will be conducted in two parts: Stage1 dose-escalation and Stage2 dose-expansion. In Stage1, patient enrolment will be proceeded according to a "Accelerated Titration + BOIN" design in order to identify the maximum-tolerated dose (MTD) or recommended dose. In Stage2, preliminary efficacy response will be assessed in patients with advanced solid tumors in use of the recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYHX2005 | Experimental | Stage1 dose-escalation: Patients with advanced solid tumors will receive escalating doses of SYHX2005 as monotherapy. Stage2 dose-expansion: Patients with advanced solid tumors will receive SYHX2005 monotherapy at recommended dose (1 or 2 ) in Stage 1 (dose escalation) to evaluate the preliminary antitumor activity of SYHX2005. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHX2005 | Drug | Tablets. Take orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose(MTD) | Maximum tolerated dose | At the end of Cycle 1 (each cycle is 28 days) |
| Overall Response Rate (ORR) in stage 2 | Overall Response Rate | up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and frequency of adverse events (AE) and serious adverse events (SAE) | Rate of adverse events (AE) and serious adverse events (SAE) | 12 months |
| Overall Response Rate (ORR) in stage 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fan, MD | Contact | +86-021-64041990 | fan.jia@zs-hospital.sh.cn |
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Overall Response Rate
| 12 months |
| Duration of Response (DOR) | Duration of Response | 12 months |
| Disease Control Rate (DCR) | Disease Control Rate | 12 months |
| Progression-Free Survival (PFS) | Progression-free survival | 12 months |
| Overall Survival (OS) | Overall Survival | 12 months |
| Pharmacokinetic profile,e.g.AUC of SYHX2005 | Area Under the Plasma Concentration Versus Time Curve (AUC) | 12 months |