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Advanced Non-Small-Cell Lung CancerPhase 1/2NCT05435274

Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer

A Phase 1/2 study testing HS-10376 in people with Advanced Non-Small-Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC) patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small-Cell Lung Cancer
What is being tested?
HS-10376
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
1 siteChina
Study dates
30 Sep 2021to 7 Oct 2025
Phase
Phase 1/2
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

  • Men or women greater than or equal to 18 years
  • Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
  • Pathological, tumor tissue samples can be used to test EGFR/HER2 Exon 20 insertion mutation by central laboratory for subjects
  • At least one measurable lesion in accordance with RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0~1
  • Estimated life expectancy >12 weeks
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  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have the evidence of non-childbearing potential
  • Signed and dated Informed Consent Form

Who cannot join

  • Treatment with any of the following:
  • Previous or current treatment with EGFR Exon 20 insertion inhibitors, HER2 Exon 20 insertion inhibitors or EGFR/HER2 Exon 20 insertion inhibitors
  • Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10376
  • Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10376
  • Local radiotherapy for palliation within 2 weeks of the first dose of HS-10376, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10376
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10376
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  • Inadequate bone marrow reserve or serious organ dysfunction
  • Uncontrolled pleural, ascites or pericardial effusion
  • Untreated, symptomatic or active central nervous system metastases
  • Severe or poorly controlled hypertension
  • Immunodeficiency disease and active infectious disease
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  • History of hypersensitivity to any active or inactive ingredient of HS-10376 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10376
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study
  • History of neuropathy or mental disorders, including epilepsy and dementia

Trial locations and contacts

1 site in 1 country.

Dingzhi Huang contact

18622221232

dingzhi72@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300181

    Dingzhi Huang, 18622221232, dingzhi72@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10376 Monotherapy in Patients With Advanced Non-small-Cell Lung Cancer

HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC) patients.

Read the detailed description

This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10376, this study has two parts: phase 1 and phase 2. The phase 1 portion consists of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10376 in subjects with advanced NSCLC and evaluate the preliminary efficacy of HS-10376. Phase 2 will be conducted to evaluate the efficacy of HS-10376 in subjects with locally advanced or metastatic NSCLC with a EGFR Exon 20 insertion mutation.

Being tested
HS-10376
Keywords
NSCLC, Non-Small Cell Lung Cancer, HS-10376, EGFR/HER2 Exon 20 insertion mutation
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • HS-10376Drug

    HS-10376 will be administered orally once daily in a continuous regimen

Study groups in NCT05435274
Study groupRoleWhat they receive
HS-10376ExperimentalPhase 1a：Dose Escalation：Subjects with advanced NSCLC will be enrolled in dose escalation cohorts. Dose escalation of HS-10376 will be done to determine maximum tolerated dose. Phase 1b：Dose Expansion：Depending on data obtained from the dose escalation part, dose expansion may proceed with multiple cohorts in subjects with advanced NSCLC having a EGFR/HER2 Exon 20 insertion mutation. Phase 2：Subjects with locally advanced or metastatic EGFR Exon 20 insertion NSCLC will be enrolled in phase 2 part to evaluate the efficacy and sufficient safety of HS-10376 as monotherapy.
Receives: Drug: HS-10376

What is being measured

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

  1. To determine the maximum tolerated dose (MTD)-Part Ia

    Number of participants with dose limiting toxicity

    Measured: From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (total 28 days)

  2. To evaluate clinical activity/efficacy of HS-10376 by assessment of objective response rate-Phase Ib/II

    Objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Measured: up to 24 months

Secondary outcomes (8)

  1. Number of participants with treatment related adverse events

    Number of participants with treatment related adverse events.

    Measured: From baseline until 28 days after the last dose

  2. Observed maximum plasma concentration (Cmax) after single dose of HS-10376

    In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10376

    Measured: From pre-dose to 120 hours after single dose on Day 1

  3. Time to reach maximum plasma concentration (Tmax) after single dose of HS-10376

    In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10376

    Measured: From pre-dose to 120 hours after single dose on Day 1

  4. Apparent terminal half-life (T1/2) after single dose of HS-10376

    Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.

    Measured: From pre-dose to 120 hours after single dose on Day 1

  5. Duration of response (DOR)

    DOR assessed by RECIST 1.1 criteria

    Measured: 24 months

  6. Disease Control Rate (DCR)

    DCR assessed by RECIST 1.1 criteria

    Measured: 24 months

  7. Progression-free survival (PFS)

    PFS assessed by RECIST 1.1 criteria

    Measured: 24 months

  8. Overall survival (OS)

    Measured: 24 months

Timeline

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

  1. First posted28 Jun 2022
  2. Study start30 Sep 2021
  3. Primary completion7 Oct 2024 (estimated)
  4. Study completion7 Oct 2025 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435274
Sponsor's protocol ID
HS-10376-101
Status last verified
Jun 2022
First submitted
23 Jun 2022
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-10376 in people with Advanced Non-Small-Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Dingzhi Huang (18622221232, dingzhi72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD)-Part Ia (time frame: From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (total 28 days)). The study lists 2 primary outcomes in all. 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 NCT05435274.

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 28 Jun 2022.

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