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A Phase 1 Study of HS-10342 In Patients With Advanced Solid Tumor

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ClinicalTrials.gov Identifier: NCT04060511
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief Summary:
HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients. Preliminary efficacy will be also investigated in this study.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: HS-10342 Phase 1 Drug: HS-10342 Phase 1

Detailed Description:
This is a phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10342 in patients with advanced solid tumor by using a "3+3" dose escalation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10342 in Patients With Advanced Solid Tumor
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: HS-10342
Each subject will receive a single dose(C0) of HS-10342 and then repeat doses(C1, C2…) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Drug: HS-10342
HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID




Primary Outcome Measures :
  1. Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342. [ Time Frame: 5 weeks ]
    The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the 5 week after the first dose.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on gender
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

    1. Pathologically confirmed solid tumor and failed from all standard treatment.
    2. At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
    3. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
    4. Life expectancy ≥ 3 months.
    5. Adequate function of major organs meets the following requirements:

      • Neutrophils ≥ 1.5×10^9/L
      • Platelets ≥ 90×10^9/L
      • Hemoglobin ≥ 90g/L
      • Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
      • ALT and AST ≤ 2.5 × ULN
      • Cr ≤ 1.5 × ULN
      • Left ventricular ejection fraction (LVEF) ≥ 40%
    6. Good compliance of patient by physician's judgement.
    7. . Signed and dated informed consent.

Exclusion Criteria:

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

    1. Previously received therapy of anti-tumor agent targeting at CDK4/6.
    2. Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
    3. Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
    4. Less than 4 weeks from large area radiotherapy.
    5. Less than 7 days from any CYP3A4 strong inhibitor, strong inducer or a narrow window of medicine or food for CYP3A4 sensitive substrate.
    6. Having joined in other clinical trials within 4 weeks.
    7. Brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed).
    8. Existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia).
    9. Uncontrollable pleural effusion or ascites.
    10. Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug.
    11. History of serious allergy events or known being allergy constitution, or have a history of allergies to the drug components of this regimen.
    12. Patients with active infection.
    13. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
    14. History of uncontrollable cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction Less than 6 moths (4) other cardiac dysfunction (judged by the physician), such as any degree of heart block or QTc prolongation, QT interval corrected by Fridericia method(QTcF) >450 ms(men) or >470 ms(women); (5)any cardiac or nephric abnormal ≥ grade 2 found in screening.
    15. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
    16. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
    17. History of neuropathy or dysphrenia, including epilepsy and dementia
    18. Determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060511


Contacts
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Contact: Datong Li 86-18652105808 lidt@hspharm.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Binhe Xu, MD         
China, Guangdong
Sun Yat-sen University Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yanxia Shi, PhD., M.D.         
Second Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Herui Yao, MD         
Principal Investigator: Qiang Liu, MD         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Min Yan, MD         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yongmei Yin, MD         
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Binhe Xu, MD Cancer Hosptial, Chinese Academy of Medical Sciences
Principal Investigator: Herui Yao, MD Second Affiliated Hospital of Sun Yat-Sen University
Principal Investigator: Qiang liu, MD Second Affiliated Hospital of Sun Yat-Sen University
Principal Investigator: Yongmei Yin, MD Jiangsu Provincial People's Hospital, Jiangsu Province, Nanjing 210029, China
Principal Investigator: Min Yan, MD Henan Cancer Hospital
Principal Investigator: Yanxia Shi, MD Sun Yat-sen University Cancer Hospital

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Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04060511     History of Changes
Other Study ID Numbers: HS-10342-101
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Hansoh Pharmaceutical Co., Ltd.:
HS-10342; CDK4/6 inhibitor, advanced solid tumor
Additional relevant MeSH terms:
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Neoplasms