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This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH4336 Tablets | Experimental | SPH4336 Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH4336 Tablets | Drug | Open-label SPH4336 Tablets :Administered by oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose(MTD) | Measurement of MTD of SPH4336 in all subjects | Up to 28 days |
| Dose-limiting toxicity (DLT) | Measurement of DLT of SPH4336 in all subjects | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. | Up to 1 year |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250013 | China | ||
| West China Hospital,Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40586764 | Derived | Jiang Y, Liang X, Sun ML, Gao G, Gong Y, Li HP, Liu J, Wang YS. Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. Oncologist. 2025 Jun 4;30(6):oyaf077. doi: 10.1093/oncolo/oyaf077. |
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From the start date of study treatment to the date of progression disease or death , whichever occurred first.
| Up to 1 year |
| Cmax | PK (Pharmacokinetics) parameters | predose,1,2,4,5,6,8,10,12,24 hours post-dose |
| Tmax | PK (Pharmacokinetics) parameters | predose,1,2,4,5,6,8,10,12,24 hours post-dose |
| Disease control rate (DCR) | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease. | Up to 1 year |
| Duration of remission (DOR) | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause. | Up to 1 year |
| Safety and tolerability | Adverse event type, incidence, duration, correlation with study drug. | Up to 1 year |
| Chengdu |
| Sichuan |
| 610044 |
| China |
| Peking University Cancer Hospital | Beijing | 100142 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |