drugset / Trial / NCT06218940

HY1272 in Patients With Locally Advanced or Metastatic Solid Tumors or Locally Advanced or Metastatic EGFRm+ NSCLC

NCT06218940

Phase 1 Not yet recruiting 40 enrolled Newsoara Biopharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label, multicenter, dose escalation study of HY1272 (administered via IV) evaluating both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in patients diagnosed with locally advanced or metastatic solid tumors (monotherapy) or locally advanced or metastatic EGFRm+ NSCLC (combination therapy). The study is designed to evaluate safety, tolerability, PK, and anti-tumor activity of HY1272 administered once weekly. Patients in the monotherapy portion of this study will receive only HY1272. Patients in the combination therapy portion of this study will receive osimertinib administered once daily (QD) with HY1272.

Timeline

Start
2024-12-01
Primary completion
2026-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HY1272 Unknown Intravenous
Background Osimertinib Small molecule 80 mg Oral