NCT07510841

JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR

A Phase I/II Clinical Study on the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, multi-center Phase I/II clinical trial, consisting of Part A: the Phase I dose escalation stage, and Part B: the Phase II expansion stage. The objective of the Phase I dose escalation stage is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of JY016 injection in patients with advanced solid tumors expressing EGFR (immunohistochemistry 1+, 2+, or 3+). In the Phase II stage, the efficacy of JY016 in pancreatic cancer, non-small cell lung cancer, esophageal cancer, colorectal cancer, and squamous cell carcinoma of the head and neck with EGFR expression will be further evaluated.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	JY016	0.08μg/kg\~30μg/kg,QW

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-05-31
• Completion: 2029-05-31
• First posted: 2026-04-06
• Last updated: 2026-04-06