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Recruiting
NCT05523947
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
Conditions: HER2-Positive Solid Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 147
Sponsor: Yuhan Corporation
Location: Dana Farber Cancer Institute Boston Massachusetts
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.
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
Source: ClinicalTrials.gov (NCT05523947). StuddyBuddy aggregates publicly available trial information.