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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle
Intravenous infusion, 6mg/Kg,28 days/cycle
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2 years
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Approximately 2 years
progression-free rate(PFR)
Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
Time frame: Approximately 2 years
Cmax
PK (Pharmacokinetics) parameters.
Time frame: Approximately 2 years
Tmax
PK (Pharmacokinetics) parameters.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 2 years
Overall Survival (OS)
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Henan Cancer Hospital
Zhengzhou, He'nan, China
RECRUITINGUnion Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGThe Central Hospital of Yongzhou
Yongzhou, Hunan, China
RECRUITINGLiaoning Cancer Hospital & Institute
Shenzhen, Liaoning, China
RECRUITINGXijing Hospital
Xi’an, Shanxi, China
RECRUITINGWest China Hospital,Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITING...and 6 more locations
Determination of the overall survival times of all patients.
Time frame: Approximately 8 years
Incidence of Adverse event
Safety and tolerability
Time frame: Approximately 2 years