Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors

Study Overview
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Brief Summary
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This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.

Official Title
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An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: SPH4336 Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced solid tumors； ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1； Life expectancy ≥ 3 months； Good organ function； According to the investigator's judgment, the patient could comply with the trial protocol; Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF). Exclusion Criteria: Received other antineoplastic therapy before the first dose； Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication; Enroll in other clinical trials and receive treatment as a subject before initial medication; Patients with allergic constitution or history of severe allergy; Hepatitis B surface antigen [HBsAg] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency; Cardiac criteria: presence of factors that may cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, and other concomitant medications known to prolong the QT interval. The presence of any unstable cardiovascular disease; Hypertension that cannot be effectively controlled after treatment; Have severe lung disease; Pregnant and lactating women; Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial; Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment; Had a definite history of neurological or mental disorders; Other circumstances considered by the investigator to be inappropriate for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPH4336 Tablets<br>SPH4336 Tablets | Drug: SPH4336 Tablets<br>* Open-label SPH4336 Tablets ：Administered by oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |