A Study of HS-10342 in Patients With Advanced Solid Tumor

NCT04060511 | Completed Phase 1

• 1 other identifier: HS-10342-101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Solid Tumor

Keywords

CDK4/6 inhibitor, advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342.

  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.

  5 weeks

Study Arms (1)

HS-10342

EXPERIMENTAL

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

Interventions

HS-10342 DRUG

HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID

HS-10342

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, 510080, China

Location

Second Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Study Officials

• Binhe Xu, MD

  Cancer Hosptial, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Herui Yao, MD

  Second Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Qiang liu, MD

  Second Affiliated Hospital, 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

  PRINCIPAL INVESTIGATOR

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: August 15, 2019
• First Posted: August 19, 2019
• Study Start: June 19, 2019
• Primary Completion: December 4, 2020
• Study Completion: September 15, 2021
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

CN (5)