NCT06218940

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

A Phase 1, Open-label, Multicenter Study to Evaluate Safety, Tolerability, PK, and Efficacy of Intravenous Administration of HY1272 in Patients With Late Phase Solid Tumors or EGFRm+NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Newsoara Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	HY1272	Each patient will receive HY1272 weely or HY1272 weely+Oshitinib 80mg P.O. daily

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-01-23
• Last updated: 2024-01-23

Regulatory

• FDA-regulated drug study