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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05905614
• Other study ID #: SPH4336-101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 3, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• SPH4336 Tablets
Open-label SPH4336 Tablets :Administered by oral

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing
China	Jinan Central Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose(MTD)	Measurement of MTD of SPH4336 in all subjects	Up to 28 days
Primary	Dose-limiting toxicity (DLT)	Measurement of DLT of SPH4336 in all subjects	Up to 28 days
Secondary	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
Secondary	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
Secondary	Cmax	PK (Pharmacokinetics) parameters	predose,1,2,4,5,6,8,10,12,24 hours post-dose
Secondary	Tmax	PK (Pharmacokinetics) parameters	predose,1,2,4,5,6,8,10,12,24 hours post-dose
Secondary	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
Secondary	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
Secondary	Safety and tolerability	Adverse event type, incidence, duration, correlation with study drug.	Up to 1 year