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

NCT06461156 | Recruiting Phase 1

• 1 other identifier: HS-10504-101
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic NSCLC

Keywords

locally advanced or metastatic NSCLC; EGFR C797S; HS-10504

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (11)

• Incidence and severity of adverse events (AEs).

  From the first dose until 28 days after the last dose

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

  From the first dose until Circle 2 Day 1

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

  From the first dose until Circle 2 Day 1

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

  From the first dose until Circle 2 Day 1

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

  From the first dose until Circle 2 Day 1

Study Arms (1)

HS-10504

EXPERIMENTAL

Subjects 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).

Drug: HS-10504

Interventions

HS-10504 DRUG

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.

HS-10504

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianxing He, PhD

CONTACT

020-83062807; drjianxing_he1@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)