Advanced Solid Tumor
Conditions
Brief summary
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.
Interventions
DRUGSPH6516 tablets
SPH6516 tablets ： Orally, once daily, 25-200mg, 28 days a cycle
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD（Maximum tolerated dose） | Approximately 2 years | Maximum tolerated dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Incidence of Treatment-Emergent Adverse Events | Approximately 2 years | Adverse event type, incidence, duration |
| 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 |
| 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. |
| half-life（T1/2） | Approximately 2 years | PK (Pharmacokinetics) |
Countries
China
Outcome results
None listed