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This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH4336 | Experimental |
| |
| Cadonilimab | Experimental |
| |
| SPH4336+ Cadonilimab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH4336 | Drug | SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From the start date of study treatment to the date of progression disease or death , whichever occurred first. | Approximately 2 years |
| 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. | Approximately 2 years |
| progression-free rate(PFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Hu | Contact | 0086-020-87343535 | xuri1104@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
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| Cadonilimab | Drug | Intravenous infusion, 6mg/Kg,28 days/cycle |
|
Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
| Approximately 2 years |
| Cmax | PK (Pharmacokinetics) parameters. | Approximately 2 years |
| Tmax | PK (Pharmacokinetics) parameters. | Approximately 2 years |
| Disease control rate (DCR) | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease. | Approximately 2 years |
| 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. | Approximately 2 years |
| Overall Survival (OS) | Determination of the overall survival times of all patients. | Approximately 8 years |
| Incidence of Adverse event | Safety and tolerability | Approximately 2 years |
| The First Affiliated Hospital,Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | He'nan | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | China |
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| The Central Hospital of Yongzhou | Recruiting | Yongzhou | Hunan | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenzhen | Liaoning | China |
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| Xijing Hospital | Recruiting | Xi’an | Shanxi | China |
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| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Peking University People's Hospital | Recruiting | Beijing | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| Shanghai Sixth People's Hospital | Recruiting | Shanghai | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | China |
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