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-10504-101

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.

2024-06-30

2026-12-31

2027-03-31

Not yet recruiting

Early phase I

230

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 230, 'type': 'ESTIMATED'}}

2024-06-14