HS-10504 for advanced or metastatic non-small-cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HS-10504 is a fourth-generation EGFR tyrosine kinase inhibitor designed to target the EGFR C797S resistance mutation. This Phase 1, single-center study in China uses dose-escalation and possible expansion cohorts to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Eligible participants have histologically confirmed locally advanced or metastatic EGFR-positive NSCLC, measurable disease per RECIST 1.1, ECOG 0-1, and prior progression on EGFR-TKIs. Patients with other oncogenic drivers, histologic transformation, or prior fourth-generation EGFR inhibitors are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* Subjects with known oncogenic driver genes other than EGFR.
* Subjects with mixed cell histologic or with phenotypic transformation.
* Treatment with any of the following:

  1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
  2. 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.
  3. 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
  4. Uncontrolled pleural effusion or ascites or pericardial effusion.
  5. Major surgery within 4 weeks before the first dose.
  6. 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.

Where it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Jianxing He, PhD
• Email: drjianxing_he1@126.com
• Phone: 020-83062807

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ASKC202 with Limertinib combo vs platinum chemo after EGFR-TKI in MET-aligned NSCLC

  This trial tests whether ASKC202 plus Limertinib works better than standard platinum-based chemotherapy for adults with locally advanced or metastatic NSCLC that has MET amplification/overexpression after failing EGFR-TKI therapy.

  Recruiting Phase 3 Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Shanghai · NCT07109531

• How HS-10506 behaves in people with moderate liver problems compared to healthy individuals

  This study tests a single 20 mg dose of HS-10506 to see how people with moderate hepatic impairment process the drug compared with people with normal liver function.

  Recruiting Phase 1 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Hefei, Anhui · NCT07844967

• HS-10504 vs platinum-based chemotherapy in EGFR C797S+ NSCLC

  This study tests whether the oral drug HS-10504 can help adults with advanced NSCLC that has the EGFR C797S mutation after prior EGFR therapy, by comparing it to standard platinum-based chemotherapy.

  Recruiting Phase 3 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Guangzhou · NCT07754123

• Oral HS-10542 for paroxysmal nocturnal hemoglobinuria

  This study will test whether the oral drug HS-10542 can reduce hemolysis and raise hemoglobin in adults with PNH, including those not fully helped by C5 inhibitor therapy.

  Recruiting Phase 1/2 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Hangzhou, Zhejiang · NCT07470762

• HS-10566 treatment in high-risk non-muscle-invasive bladder cancer where surgery isn’t an option

  This study tests HS-10566 to see if it can help people with high-risk NMIBC who can’t or won’t have radical cystectomy.

  Recruiting at 2 sites Phase 1/2 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07468851

• Aumolertinib for European adults with EGFR‑mutant advanced non‑small cell lung cancer

  This Phase 1 trial tests daily oral aumolertinib in European adults with advanced or metastatic NSCLC that has activating EGFR mutations to see how the drug is processed in the body and whether it is safe and tolerable.

  Recruiting at 6 sites Phase 1 Jiangsu Hansoh Pharmaceutical Co., Ltd. · Banja Luka and 5 other locations · NCT07130916

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.