RecruitingPhase 1Phase 2NCT06975410

Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor

Yuhan Corporation

Enrollment

80 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor Locally Advanced Solid Tumor EGFR Overexpression

Summary

This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called YH32364 — which targets a protein called EGFR found on the surface of certain cancer cells — in people with advanced solid tumors where the cancer has too much EGFR. **You may be eligible if...** - You are 18 or older with locally advanced or metastatic solid tumors - Your tumor has been tested and shows EGFR overexpression - You have at least one measurable tumor on imaging - You are physically well (ECOG 0 or 1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active brain metastases that are not stable - You have serious heart, lung, liver, or kidney conditions - You have had severe reactions to prior EGFR-targeting drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYH32364

Dose Escalation Part: In this part, 6 dose levels are planned and approximately 30 patients will be enrolled. After each dose level, Safety Review Committee (SRC) will evaluate the available safety, tolerability, PK of YH32364 to decide the next dose. Dose Expansion Part: 50 participants with previously treated locally advanced or metastatic EGFR overexpressing HNSCC other than NPC will be randomized 1:1 ratio to each dose. (Cohort 1: Participants with locally advanced or metastatic EGFR overexpressing HNSCC other than NPC, whose disease progressed after or who are intolerable to all the available standard treatment)