Status:
COMPLETED
A Study of HS-10342 in Patients With Advanced Solid Tumor
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advan...
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.
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- Pathologically confirmed solid tumor and failed from all standard treatment.
- At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
- Life expectancy ≥ 3 months.
- 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%
- Good compliance of patient by physician's judgement.
- . Signed and dated informed consent.
Exclusion
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- Previously received therapy of anti-tumor agent targeting at CDK4/6.
- Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
- Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
- Less than 4 weeks from large area radiotherapy.
- Less than 7 days from any CYP3A4 strong inhibitor, strong inducer or a narrow window of medicine or food for CYP3A4 sensitive substrate.
- Having joined in other clinical trials within 4 weeks.
- Brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed).
- Existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia).
- Uncontrollable pleural effusion or ascites.
- Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug.
- History of serious allergy events or known being allergy constitution, or have a history of allergies to the drug components of this regimen.
- Patients with active infection.
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
- 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.
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- History of neuropathy or dysphrenia, including epilepsy and dementia
- Determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment.
Key Trial Info
Start Date :
June 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04060511
Start Date
June 19 2019
End Date
September 15 2021
Last Update
March 9 2023
Active Locations (5)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China, 510080
3
Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003