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

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.

Disease Sites:

Miscellaneous

Staging:

Phase I/II

Age Group:

Adults

Therapies:

Mol. targeted/Immunotherapy/Biologics

Drugs:

YH32367

Principal Investigator(s):

Heumann, Thatcher

Scope:

International

Participating Institutions:

Vanderbilt University

Open Date:

11-04-2025

Trial Type:

Treatment

Protocol ID:

VICC-DTMDT24023

National Clinical Trial ID:

NCT05523947

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

ALL

Accepts Healthy Volunteers?:

false

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

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

Eligibility