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

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

Last updated 9 months ago

Study ID

HS-10504-101

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 10 months ago

What is this trial about?

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.

What are the participation requirements?

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.