NCT06050980 Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation
| NCT ID | NCT06050980 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2025-08-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, Male and female patients, at time of signing informed consent form (ICF). 2. ECOG=0-1, with no deterioration in 2 weeks before first dose of HSK40118. 3. Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC. 4. Patients will provide blood or tumor sample according to their own willingness. 5. Patients in Phase Ia and Ib will fulfill the different criteria of the following: Phase Ia(Part A): Previous treatment with at least one EGFR-TKI, including 1st, 2nd and 3rd-generation EGFR-TKI; Phase Ia(Part B)/Phase Ib: Previous treatment with 3rd-generation EGFR-TKI. 6. tumour lesions/lymph nodes: Phase Ia(Part A): Patients should have at least one assessable tumour lesions/malignant lymph nodes; Phase Ia(Part B) /Phase Ib: Patients should have at least one measurable tumour lesions/malignant lymph nodes. 7. Life expectancy ≥ 3 months. 8. Adequate hematologic and organ function per protocol. 9. Women of child