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.
Pathologically confirmed HER2-positive
Mandatory provision of tumor tissue sample
Patients who have at least one measurable lesion
Mandatory provision of tumor tissue sample
Uncontrolled central nervous system (CNS) metastases
Spinal cord compression
Carcinomatous meningitis
Acute coronary syndromes
Single group
YH32367
DrugDose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8. Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2). Each cohort will enroll approximately 75 and 40 patients, respectively.
Treatment-emergent adverse events (TEAEs) up to Day 21
To assess the safety and tolerability of YH32367
Objective Response Rate (ORR)
To assess the ORR of YH32367 at the recommended Phase 2 dose (RP2D) according to RECIST v1.1 by blinded independent central reviews (BICR)
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the PK of YH32367
maximum observed serum concentration (Cmax)
To characterize the PK of YH32367
time to reach Cmax (Tmax)
To characterize the PK of YH32367
Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies
To explore the immunogenicity of YH32367
Immune ORR (iORR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Immune Duration of Response (iDOR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Immune PFS (iPFS)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
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