Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YH32367.
- Who it may be relevant to
- Registry conditions: HER2-Positive Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors
Overview
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.
Detailed description
YH32367, a novel HER2/4-1BB bispecific antibody (BsAb), simultaneously targets HER2 and h4-1BB and binds to both targets. YH32367 exhibits a strong 4-1BB signal activation as well as blocking of HER2 signaling in HER2-expressing tumor cells. YH32367 stimulates IFN-γ secretion from T cells and thereby induces tumor cells lysis.
This is a Phase 1/2, open-label, multicenter, first-in-human study of YH32367. This 2-part study will include both a Dose Escalation part, to identify the Maximum Tolerated Dose (MTD) and/or two dose levels for RP2D selection, and a Dose Expansion part, to determine RP2D and to confirm the safety, tolerability and efficacy of YH32367 at the RP2D.
Interventions
- Drug YH32367
Dose 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 tr
Primary outcome measures
- Treatment-emergent adverse events (TEAEs) up to Day 21 [Time frame: in dose escalation part, an average of 21 days]
- Objective Response Rate (ORR) [Time frame: through dose expansion part completion, approximately 2.5 year]
Secondary outcome measures (12)
- Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast) [Time frame: up to 66 weeks]
- maximum observed serum concentration (Cmax) [Time frame: up to 66 weeks]
- time to reach Cmax (Tmax) [Time frame: up to 66 weeks]
- Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies [Time frame: through study completion, approximately 3.5 year]
- Objective Response Rate (ORR) [Time frame: through study completion, approximately 3.5 year]
- Duration of Response (DoR) [Time frame: through study completion, approximately 3.5 year]
- Disease Control Rate (DCR) [Time frame: through study completion, approximately 3.5 year]
- Depth of Response [Time frame: through study completion, approximately 3.5 year]
- Time to Response [Time frame: through study completion, approximately 3.5 year]
- Progression-free survival (PFS) [Time frame: through study completion, approximately 3.5 year]
- TEAEs [Time frame: through dose expansion part completion, approximately 2.5 year]
- Overall Survival (OS) [Time frame: through study completion, approximately 3.5 year]
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
- Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 13 centers
- CHA Bundang Medical Center — Seongnam-si
- Catholic University of Korea St. Vincent's Hospital — Suwon
- Ajou University Hospital — Suwon
- Gyeongsang National University Hospital — Jinju
- Chungbuk National University Hospital — Cheongju-si
- Gachon Gil University Medical Center — Incheon
- Korea University Anam Hospital — Seoul
- Seoul National University Hospital — Seoul
- … and 5 more centers
Australia · 4 centers
- Southern Oncology Clinical Research Unit — Adelaide
- Austin Health — Melbourne
- Breast Cancer Research Centre - WA — Perth
- Blacktown Hospital — Sydney
United States · 2 centers
- Dana Farber Cancer Institute — Boston
- Vanderbilt Ingram Cancer Center — Nashville
Identifiers
NCT: NCT05523947 · YH32367-101