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

March 7, 2023 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

A Phase 1, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10342 in Patients With Advanced Solid Tumor

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Sun Yat-sen University Cancer Hospital
      • Guangzhou, Guangdong, China, 510120
        • Second Affiliated Hospital of Sun Yat-sen University
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-10342-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings