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Advanced Solid TumorPhase 1NCT04060511

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

A Phase 1 study testing HS-10342 in people with Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-10342
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesChina
Study dates
19 Jun 2019to 15 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, Guangdong, 510080

  • Second Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
HS-10342
Keywords
CDK4/6 inhibitor, advanced solid tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10342Drug

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

Study groups in NCT04060511
Study groupRoleWhat they receive
HS-10342ExperimentalEach 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.
Receives: Drug: HS-10342

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start19 Jun 2019
  3. Primary completion4 Dec 2020
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060511
Sponsor's protocol ID
HS-10342-101
Status last verified
Feb 2023
First submitted
15 Aug 2019
Last updated
9 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10342 in people with Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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