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

Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05905614
Collaborator
(none)
29
Enrollment
4
Locations
1
Arm
39.9
Anticipated Duration (Months)
7.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: SPH4336 Tablets
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 3, 2020
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPH4336 Tablets

SPH4336 Tablets

Drug: SPH4336 Tablets
Open-label SPH4336 Tablets ：Administered by oral

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose（MTD） [Up to 28 days]

    Measurement of MTD of SPH4336 in all subjects

  2. Dose-limiting toxicity (DLT) [Up to 28 days]

    Measurement of DLT of SPH4336 in all subjects

Secondary Outcome Measures

  1. Objective response rate (ORR) [Up to 1 year]

    Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

  2. Progression-free survival (PFS) [Up to 1 year]

    From the start date of study treatment to the date of progression disease or death , whichever occurred first.

  3. Cmax [predose,1,2,4,5,6,8,10,12,24 hours post-dose]

    PK (Pharmacokinetics) parameters

  4. Tmax [predose,1,2,4,5,6,8,10,12,24 hours post-dose]

    PK (Pharmacokinetics) parameters

  5. Disease control rate (DCR) [Up to 1 year]

    DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.

  6. Duration of remission (DOR) [Up to 1 year]

    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.

  7. Safety and tolerability [Up to 1 year]

    Adverse event type, incidence, duration, correlation with study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinan Central Hospital Jinan Shandong China 250013
2 West China Hospital，Sichuan University Chengdu Sichuan China 610044
3 Peking University Cancer Hospital Beijing China 100142
4 Chongqing University Cancer Hospital Chongqing China 400030

Sponsors and Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Pharmaceuticals Holding Co., Ltd
ClinicalTrials.gov Identifier:
NCT05905614
Other Study ID Numbers:
  • SPH4336-101
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jun 15, 2023