Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors

NCT ID: NCT05905614

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2023-10-26

Brief Summary

This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

SPH4336 Tablets

SPH4336 Tablets

Group Type: EXPERIMENTAL

SPH4336 Tablets

Intervention Type: DRUG

Open-label SPH4336 Tablets ：Administered by oral

Interventions

SPH4336 Tablets

Open-label SPH4336 Tablets ：Administered by oral

Intervention Type: DRUG

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.

• 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

Jinan Central Hospital

Jinan, Shandong, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Peking University Cancer Hospital

Beijing, , China

Chongqing University Cancer Hospital

Chongqing, , China

Countries

China

References

Jiang Y, Liang X, Sun ML, Gao G, Gong Y, Li HP, Liu J, Wang YS. Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. Oncologist. 2025 Jun 4;30(6):oyaf077. doi: 10.1093/oncolo/oyaf077.

Reference Type: DERIVED

PMID: 40586764 (View on PubMed)

Other Identifiers

SPH4336-101

Identifier Type: -

Identifier Source: org_study_id