Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

RecruitingPhase 1/2

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

\[Dose Escalation Part\]

* Pathologically confirmed HER2-positive
* Mandatory provision of tumor tissue sample

\[Dose Expansion Part\]

* Patients who have at least one measurable lesion
* Mandatory provision of tumor tissue sample

  1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
  2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer

Exclusion Criteria:

* Uncontrolled central nervous system (CNS) metastases
* Spinal cord compression
* Carcinomatous meningitis
* Acute coronary syndromes
* Heart failure
* Interstitial lung disease (ILD)
* Pneumonitis
* History of a second primary cancer
* Human immunodeficiency virus (HIV)
* Active chronic hepatitis B
* Hepatitis C
* Systemic steroid therapy
* Autoimmune disease

About the study

This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.

What is being tested

YH32367 (drug)

Sponsor: Yuhan Corporation · Participants: 147 · Started: Aug 26, 2022

Contact the study team

Clinical Operation Team 1 · Phone: +82-2-828-0065
Heayeon Yoo · Phone: +82-2-828-0065

Official record on ClinicalTrials.gov — NCT05523947

Locations in the U.S.

Tennessee

Vanderbilt Ingram Cancer Center, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.