Clinical trial NCT05905614: Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
Official title: An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 29
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: This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed advanced solid tumors；
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
3. Life expectancy ≥ 3 months；
4. Good organ function；
5. According to the investigator's judgment, the patient could comply with the trial protocol;
6. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).

Exclusion Criteria:

1. Received other antineoplastic therapy before the first dose；
2. Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
3. Enroll in other clinical trials and receive treatment as a subject before initial medication;
4. Patients with allergic constitution or history of severe allergy;
5. Hepatitis B surface antigen \[HBsAg\] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency;
6. Cardiac criteria: presence of factors that may cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, and other concomitant medications known to prolong the QT interval. The presence of any unstable cardiovascular disease;
7. Hypertension that cannot be effectively controlled after treatment;
8. Have severe lung disease;
9. Pregnant and lactating women;
10. Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
11. Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
12. Had a definite history of neurological or mental disorders;
13. Other circumstances considered by the investigator to be inappropriate for participation in the study.

Primary outcomes:
measure: Maximum tolerated dose（MTD）
timeFrame: Up to 28 days
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 1 year
measure: Progression-free survival (PFS)
timeFrame: Up to 1 year
measure: Cmax
timeFrame: predose,1,2,4,5,6,8,10,12,24 hours post-dose
measure: Tmax
timeFrame: predose,1,2,4,5,6,8,10,12,24 hours post-dose
measure: Disease control rate (DCR)
timeFrame: Up to 1 year
measure: Duration of remission (DOR)
timeFrame: Up to 1 year
measure: Safety and tolerability
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
Study officials:
References: