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

• Status: Not yet recruiting
• Trial end date: 2026-10-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

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 breast cancer

2. Cohort 2: Pathologically confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma

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