Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
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.
Miscellaneous
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
YH32367
Heumann, Thatcher
International
Vanderbilt University
11-04-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
\[Dose Escalation Part\]
\[Dose Escalation Part\]
Pathologically confirmed HER2-positive
Pathologically confirmed HER2-positive
Mandatory provision of tumor tissue sample
Mandatory provision of tumor tissue sample
\[Dose Expansion Part\]
\[Dose Expansion Part\]
Patients who have at least one measurable lesion
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
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
Uncontrolled central nervous system (CNS) metastases
Spinal cord compression
Spinal cord compression
Carcinomatous meningitis
Carcinomatous meningitis
Acute coronary syndromes
Acute coronary syndromes
Heart failure
Heart failure
Interstitial lung disease (ILD)
Interstitial lung disease (ILD)
Pneumonitis
Pneumonitis
History of a second primary cancer
History of a second primary cancer
Human immunodeficiency virus (HIV)
Human immunodeficiency virus (HIV)
Active chronic hepatitis B
Active chronic hepatitis B
Hepatitis C
Hepatitis C
Systemic steroid therapy
Systemic steroid therapy
Autoimmune disease
Autoimmune disease
\[Dose Escalation Part\]
\[Dose Escalation Part\]
Pathologically confirmed HER2-positive
Pathologically confirmed HER2-positive
Mandatory provision of tumor tissue sample
Mandatory provision of tumor tissue sample
\[Dose Expansion Part\]
\[Dose Expansion Part\]
Patients who have at least one measurable lesion
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
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
Uncontrolled central nervous system (CNS) metastases
Spinal cord compression
Spinal cord compression
Carcinomatous meningitis
Carcinomatous meningitis
Acute coronary syndromes
Acute coronary syndromes
Heart failure
Heart failure
Interstitial lung disease (ILD)
Interstitial lung disease (ILD)
Pneumonitis
Pneumonitis
History of a second primary cancer
History of a second primary cancer
Human immunodeficiency virus (HIV)
Human immunodeficiency virus (HIV)
Active chronic hepatitis B
Active chronic hepatitis B
Hepatitis C
Hepatitis C
Systemic steroid therapy
Systemic steroid therapy
Autoimmune disease
Autoimmune disease
