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Locally Advanced or Metastatic NSCLCPhase 1NCT06461156

A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

A Phase 1 study testing HS-10504 in people with Locally 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-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced or Metastatic NSCLC
What is being tested?
HS-10504
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteChina
Study dates
26 Jun 2024to 31 Mar 2027
Phase
Phase 1
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

  • Males or females, aged ≥ 18 years.
  • Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • Progressive disease on or after prior treatment with EGFR-TKIs.
  • Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.
  • At least 1 target lesion according to RECIST 1.1.
  • ECOG PS score: 0-1.
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  • Estimated life expectancy> 12 weeks.
  • Men or women should be using adequate contraceptive measures throughout the study.
  • Women must have the evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Who cannot join

  • Subjects with known oncogenic driver genes other than EGFR.
  • Subjects with mixed cell histologic or with phenotypic transformation.
  • Treatment with any of the following:
  • Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
  • Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.
  • Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose
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  • Uncontrolled pleural effusion or ascites or pericardial effusion.
  • Major surgery within 4 weeks before the first dose.
  • CNS metastases with symptomatic or active progression.
  • Subjects who have any grade ≥2 residual toxicities from prior therapies.
  • Subjects who have history of other primary malignancies.
  • Inadequate bone marrow reserve or hepatic and renal functions.
  • Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.
  • Hypersensitivity to any ingredient of HS-10504.
  • Moderate to severe pulmonary diseases.
  • Prior history of significant neurological or mental disorders.
  • Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
  • Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
  • Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianxing He, PhD contact

020-83062807

drjianxing_he1@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10504 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC）

HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.

Being tested
HS-10504
Keywords
locally advanced or metastatic NSCLC, EGFR C797S, HS-10504
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-10504Drug

    HS-10504 will be administered orally once daily in a continuous regimen. Participants will continue treatment until experiencing objective disease progression or meeting other protocol-specified criteria for discontinuation of study treatment.

Study groups in NCT06461156
Study groupRoleWhat they receive
HS-10504ExperimentalSubjects with advanced or metastatic NSCLC will be enrolled in dose-escalation stage. Dose escalation of HS-10504 will be done to determine maximum tolerated dose(Dose Escalation Stage). Depending on data obtained from the dose-escalation stage, dose expansion may proceed with in subjects with advanced or metastatic NSCLC having an EGFR C797S mutation. It can be conducted at the potentially safe and effective doses(Dose Expansion Stage).
Receives: Drug: HS-10504

What is being measured

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

  1. the maximum tolerated dose (MTD) or the maximum applicable dose (MAD)

    To determine the MTD or MAD for further evaluation of oral administration of HS-10504 in subjects with NSCLC

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

Secondary outcomes (11)

  1. Incidence and severity of adverse events (AEs).

    Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.

    Measured: From the first dose until 28 days after the last dose

  2. maximum plasma concentration (Cmax) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504

    Cmax is the maximum observed concentration

    Measured: From the first dose until Circle 2 Day 1

  3. Time to reach maximum plasma concentration (Tmax) for the first dose and multiple adminitration of HS-10504 (and its major matabolite)

    Tmax is defined as time to reach maximum observed plasma concentration

    Measured: From the first dose until Circle 2 Day 1

  4. half-life (T1/2) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504

    half-life is the time measured for the concentration to decrease by one half

    Measured: From the first dose until Circle 2 Day 1

  5. Area under the curve (AUC) of HS-10504 (and its major matabolite) for the first dose and multiple dose adminitration of HS-10504

    The AUC is defined as the area under the plasma concentration-time curve

    Measured: From the first dose until Circle 2 Day 1

  6. Trough plasma concentration (Ctrough) of HS-10504 (and its major matabolite)

    Ctrough is the observed plasma concentration immediately prior to the next dose administration

    Measured: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months

  7. Objective response rate (ORR)

    ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: up to 24 months

  8. Disease Control Rate (DCR)

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD)

    Measured: up to 24 months

  9. Duration of response (DOR)

    Duration of response (DoR) determined by investigators according to RECIST 1.1. DoR was defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used

    Measured: up to 24 months

  10. Progression-free survival (PFS)

    Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.

    Measured: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months

  11. Overall survival (OS), only for dose-expansion stage subjects

    OS was defined as the time from the first dose or random assignment (if any) to death from any cause

    Measured: From the first dose up to death or withdrawal from study, whichever came first, assessed up to 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 posted14 Jun 2024
  2. Study start26 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461156
Sponsor's protocol ID
HS-10504-101
Status last verified
Aug 2026
First submitted
5 Jun 2024
Last updated
31 Aug 2026
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 study testing HS-10504 in people with Locally 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 10 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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 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?

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 Jianxing He, PhD (020-83062807, drjianxing_he1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the maximum tolerated dose (MTD) or the maximum applicable dose (MAD) (time frame: From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (21 days).). 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 NCT06461156.

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 31 Aug 2026.

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