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

NCT05905614 | Completed Phase 1

• 1 other identifier: SPH4336-101
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose（MTD）

  Measurement of MTD of SPH4336 in all subjects

  Up to 28 days

• Dose-limiting toxicity (DLT)

  Measurement of DLT of SPH4336 in all subjects

  Up to 28 days

Secondary Outcomes (7)

• Objective response rate (ORR)

  Up to 1 year

• Progression-free survival (PFS)

  Up to 1 year

• Cmax

  predose,1,2,4,5,6,8,10,12,24 hours post-dose

• Tmax

  predose,1,2,4,5,6,8,10,12,24 hours post-dose

• Disease control rate (DCR)

  Up to 1 year

Study Arms (1)

SPH4336 Tablets

EXPERIMENTAL

SPH4336 Tablets

Drug: SPH4336 Tablets

Interventions

SPH4336 Tablets DRUG

Open-label SPH4336 Tablets ：Administered by oral

SPH4336 Tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Received other antineoplastic therapy before the first dose；
• Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
• Enroll in other clinical trials and receive treatment as a subject before initial medication;
• Patients with allergic constitution or history of severe allergy;
• 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;
• 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;
• Hypertension that cannot be effectively controlled after treatment;
• Have severe lung disease;
• Pregnant and lactating women;
• Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
• Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
• Had a definite history of neurological or mental disorders;
• Other circumstances considered by the investigator to be inappropriate for participation in the study.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (4)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610044, China

Location

Peking University Cancer Hospital

Beijing, 100142, China

Location

Chongqing University Cancer Hospital

Chongqing, 400030, China

Location

Related Publications (1)

• 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.

  PMID: 40586764 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 15, 2023
• Study Start: November 3, 2020
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (4)