Clinical trial NCT06266923: A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: MTD（Maximum tolerated dose）
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Approximately 2 years
measure: Peak Plasma Concentration (Cmax）
timeFrame: Approximately 2 years
measure: Peak time（Tmax）
timeFrame: Approximately 2 years
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Approximately 2 years
measure: half-life（T1/2）
timeFrame: Approximately 2 years
measure: Objective response rate(ORR)
timeFrame: Approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Study officials:
References: