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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SPH4336 Tablets

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Peking University Cancer Hospital
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Hospital，Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPH4336 Tablets	Drug: SPH4336 Tablets; Open-label SPH4336 Tablets ：Administered by oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	Up to 1 year
Progression-free survival (PFS)	From the start date of study treatment to the date of progression disease or death , whichever occurred first.	Up to 1 year
Cmax	PK (Pharmacokinetics) parameters	predose,1,2,4,5,6,8,10,12,24 hours post-dose
Tmax	PK (Pharmacokinetics) parameters	predose,1,2,4,5,6,8,10,12,24 hours post-dose
Disease control rate (DCR)	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.	Up to 1 year
Duration of remission (DOR)	DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.	Up to 1 year
Safety and tolerability	Adverse event type, incidence, duration, correlation with study drug.	Up to 1 year

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SPH4336-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No