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

NCT ID: NCT06266923

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2023-11-01

Brief Summary

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

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPH6516 tablets

Group Type: EXPERIMENTAL

SPH6516 tablets

Intervention Type: DRUG

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

Interventions

SPH6516 tablets

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, , China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

Shanghai, , China

Countries

China

Other Identifiers

SPH6516-101

Identifier Type: -

Identifier Source: org_study_id