Trial Title:
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
NCT ID:
NCT05523947
Condition:
HER2-Positive Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
YH32367
HER2/4-1BB bispecific antibody
Solid tumor
Breast cancer
Gastric cancer
HER2-positive
Biliary tract cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YH32367
Description:
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 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 65 and 40 patients, respectively.
Arm group label:
YH32367
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Oncology Clinical Research Unit
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health
Address:
City:
Melbourne
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Breast Cancer Research Centre - WA
Address:
City:
Perth
Country:
Australia
Status:
Withdrawn
Facility:
Name:
Blacktown Hospital
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam
Zip:
13496
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, St. Mary's hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Not yet recruiting
Start date:
August 26, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Yuhan Corporation
Agency class:
Industry
Source:
Yuhan Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523947
