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Advanced or Metastatic NSCLCPhase 1/2NCT05435248

Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

A Phase 1/2 study testing HS-10375 in people with Advanced or Metastatic NSCLC, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic NSCLC
What is being tested?
HS-10375
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
1 siteChina
Study dates
2 Mar 2022to 31 Mar 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II 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 C797S inhibitors.
  • Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.
  • Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.
  • Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375.
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  • Inadequate bone marrow reserve or serious organ dysfunction.
  • Uncontrolled pleural, ascites or pericardial effusion.
  • Known and untreated, or active central nervous system metastases.
  • Active autoimmune diseases or 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-10375 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10375.
  • 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. Contact the study team or a site near you to ask about taking part.

Li Zhang, Master contact

13902282893

zhangli@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Zhang, 13902282893, zhangli@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.

Being tested
HS-10375
Keywords
Advanced or metastatic NSCLC, EGFR C797S mutation, HS-10375
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-10375Drug

    HS-10375 will be administered orally once daily in a continuous regimen

Study groups in NCT05435248
Study groupRoleWhat they receive
HS-10375ExperimentalExperimental: HS-10375（Phase 1a：Dose Escalation） Subjects with advanced or metastatic NSCLC will be enrolled in dose escalation cohorts. Dose escalation of HS-10375 will be done to determine maximum tolerated dose. Experimental: HS-10375（Phase 1b：Dose Expansion） Depending on data obtained from the dose escalation part, dose expansion may proceed with multiple cohorts in subjects with advanced or metastatic NSCLC having a EGFR C797S mutation. Experimental: HS-10375（Phase 2） Subjects with locally advanced or metastatic EGFR C797S mutant NSCLC will be enrolled in phase 2 part to evaluate the efficacy and sufficient safety of HS-10375 as monotherapy.
Receives: Drug: HS-10375

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 (28 days)

  2. To evaluate clinical activity/efficacy of HS-10375 by assessment of objective response rate-Part Ib/II

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

    Measured: Time Frame: 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-10375

    In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10375

    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-10375

    In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10375

    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-10375

    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 start2 Mar 2022
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2026 (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
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435248
Sponsor's protocol ID
HS-10375-101
Status last verified
Oct 2024
First submitted
23 Jun 2022
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhan J, Xue J, Wu L, Zhang Z, Wang Q, Ma Y, Huang Y, Yang Y, Zhao Y, Fang W, Zhang Y, Liu Q, Xu W, Yang Y, Chen Z, Song B, Sun D, Sun X, Gao P, Zhao H, Zhang L. HS-10375, a selective EGFR C797S tyrosine kinase inhibitor, in advanced non-small cell lung cancer. J Transl Med. 2025 Jun 4;23(1):628. doi: 10.1186/s12967-025-06613-0.

    PubMed 40468352

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-10375 in people with Advanced or Metastatic NSCLC, 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 16 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Li Zhang, Master (13902282893, zhangli@sysucc.org.cn), 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 (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 NCT05435248, which also lists 1 linked publication.

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 4 Nov 2024.

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