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

Shanghai Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SPH6516 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06266923

SPH6516-101

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

SPH6516 tablets

Experimental group

Treatment:

Drug: SPH6516 tablets