drugset / Trial / NCT06590194

PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT06590194 ↗

Phase 1/2 Not yet recruiting 96 enrolled Suzhou Puhe Pharmaceutical Technology Co., LTD
Non-randomizedSequentialOpen-labelTreatment

Summary

The study will contain three stages: Phase I includes dose escalation phase (i.e., phase Ia) and dose expansion phase (i.e., phase Ib). Once the dosage regimen is confirmed, the sponsor can decide to start the cohort expansion phase (i.e., phase IIa)

Timeline

Start
2024-09-10
Primary completion
2026-06-30
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject PH009-1 Unknown 75 mg Oral
Subject PH009-1 Unknown 150 mg Oral
Subject PH009-1 Unknown 300 mg Oral
Subject PH009-1 Unknown 450 mg Oral
Subject PH009-1 Unknown 600 mg Oral
Subject PH009-1 Unknown 750 mg Oral