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

Early Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SPH6516 tablets

• Registration Number: NCT06266923
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Primary Completion: 2023-04-20
• Study Completion: 2023-11-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPH6516 tablets	SPH6516 tablets	-

Primary Outcome Measures

Name	Time	Method
MTD（Maximum tolerated dose）	Approximately 2 years	Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	Approximately 2 years	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
half-life（T1/2）	Approximately 2 years	PK (Pharmacokinetics)
Incidence of Treatment-Emergent Adverse Events	Approximately 2 years	Adverse event type, incidence, duration
Peak Plasma Concentration (Cmax）	Approximately 2 years	PK (Pharmacokinetics)
Peak time（Tmax）	Approximately 2 years	PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC)	Approximately 2 years	PK (Pharmacokinetics)
Progression-free survival (PFS)	Approximately 2 years	The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.

Trial Locations

Locations (2)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine; 🇨🇳 Shanghai, China