A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06266923
• Other study ID #: SPH6516-101
• Status: Completed
• Phase: Early Phase 1
• Start date: January 20, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Advanced solid tumors;

2. The ECOGscore is 0 to 1.

3. Expected survival =3 months.

4. Good organ function before first use of the investigational drug.

5. Any toxicity associated with previous antitumor therapy must have returned to = grade 1.

6. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person.

Exclusion Criteria:

1. Subjects who have received certain treatment in the prescribed period prior to their first medication;

2. Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication;

3. Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication;

4. Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption;

5. Subjects with allergic constitution or a history of severe allergies;

6. Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency;

7. Subjects with a history or evidence of high risk cardiovascular disease;

8. Subjects with severe lung disease;

9. Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period;

10. Subjects with a clear history of neurological or psychiatric disorders;

11. Other situations in which the investigator did not consider it appropriate to participate in the study.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SPH6516 tablets
SPH6516 tablets : Orally, once daily, 25-200mg, 28 days a cycle

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Ruijin Hospital, Shanghai Jiaotong University School Of Medicine	Shanghai

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	MTD(Maximum tolerated dose)	Maximum tolerated dose	Approximately 2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 2 years
Secondary	Peak Plasma Concentration (Cmax)	PK (Pharmacokinetics)	Approximately 2 years
Secondary	Peak time(Tmax)	PK (Pharmacokinetics)	Approximately 2 years
Secondary	Area under the plasma concentration versus time curve (AUC)	PK (Pharmacokinetics)	Approximately 2 years
Secondary	half-life(T1/2)	PK (Pharmacokinetics)	Approximately 2 years
Secondary	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
Secondary	Progression-free survival (PFS)	The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.	Approximately 2 years