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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SPH4336 Tablets

• Registration Number: NCT05905614
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-03
• Study First Submitted: 2023-05-29
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. Histologically or cytologically confirmed advanced solid tumors；
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
3. Life expectancy ≥ 3 months；
4. Good organ function；
5. According to the investigator's judgment, the patient could comply with the trial protocol;
6. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).

Exclusion Criteria

1. Received other antineoplastic therapy before the first dose；
2. Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
3. Enroll in other clinical trials and receive treatment as a subject before initial medication;
4. Patients with allergic constitution or history of severe allergy;
5. 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;
6. 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;
7. Hypertension that cannot be effectively controlled after treatment;
8. Have severe lung disease;
9. Pregnant and lactating women;
10. Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
11. Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
12. Had a definite history of neurological or mental disorders;
13. Other circumstances considered by the investigator to be inappropriate for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPH4336 Tablets	SPH4336 Tablets	SPH4336 Tablets

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose（MTD）	Up to 28 days	Measurement of MTD of SPH4336 in all subjects
Dose-limiting toxicity (DLT)	Up to 28 days	Measurement of DLT of SPH4336 in all subjects

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 1 year	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Progression-free survival (PFS)	Up to 1 year	From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Cmax	predose,1,2,4,5,6,8,10,12,24 hours post-dose	PK (Pharmacokinetics) parameters
Tmax	predose,1,2,4,5,6,8,10,12,24 hours post-dose	PK (Pharmacokinetics) parameters
Disease control rate (DCR)	Up to 1 year	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Duration of remission (DOR)	Up to 1 year	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.
Safety and tolerability	Up to 1 year	Adverse event type, incidence, duration, correlation with study drug.

Trial Locations

Locations (4)

West China Hospital，Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

Peking University Cancer Hospital; 🇨🇳 Beijing, China

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, China