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JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR

NCT07510841 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-04-06

No results posted yet for this study

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

DRUG

JY016

0.08μg/kg\~30μg/kg,QW

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-05-31
Completion
2029-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510841 on ClinicalTrials.gov