Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
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
1 other identifier
interventional
147
3 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedStudy Start
First participant enrolled
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
February 24, 2026
February 1, 2026
5.6 years
August 24, 2022
February 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment-emergent adverse events (TEAEs) up to Day 21
To assess the safety and tolerability of YH32367
in dose escalation part, an average of 21 days
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)
through dose expansion part completion, approximately 2.5 year
Secondary Outcomes (12)
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
up to 66 weeks
maximum observed serum concentration (Cmax)
up to 66 weeks
time to reach Cmax (Tmax)
up to 66 weeks
Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies
through study completion, approximately 3.5 year
Objective Response Rate (ORR)
through study completion, approximately 3.5 year
- +7 more secondary outcomes
Other Outcomes (3)
Immune ORR (iORR)
through study completion, approximately 3.5 year
Immune Duration of Response (iDOR)
through study completion, approximately 3.5 year
Immune PFS (iPFS)
through study completion, approximately 3.5 year
Study Arms (1)
YH32367
EXPERIMENTALDose Escalation Part: 8 Cohorts. In Dose Escalation part, patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts. Dose Expansion Part: 2 Cohorts (Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). Dose Expansion 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).
Interventions
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 approximately 75 and 40 patients, respectively.
Eligibility Criteria
You may qualify if:
- \[Dose Escalation Part\]
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Southern Oncology Clinical Research Unit
Adelaide, Australia
Austin Health
Melbourne, Australia
Breast Cancer Research Centre - WA
Perth, Australia
Blacktown Hospital
Sydney, Australia
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
Gachon Gil University Medical Center
Incheon, 21565, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, St. Mary's hospital
Seoul, 06591, South Korea
Ulsan University Hospital
Ulsan, 44437, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyejin Choi
Severance Hospital
- PRINCIPAL INVESTIGATOR
Kyu-pyo Kim
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Do-Youn Oh
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Joon Oh Park
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Ganessan Kichenadasse
Southern Oncology Clinical Research Unit
- PRINCIPAL INVESTIGATOR
Jennifer Man
Blacktown Hospital
- PRINCIPAL INVESTIGATOR
Arlene Chan
Breast Cancer Research Centre WA
- PRINCIPAL INVESTIGATOR
Ju Won Kim
Korea University Anam Hospital
- PRINCIPAL INVESTIGATOR
Myung Ah Lee
The Catholic University of Korea, St. Mary's hospital
- PRINCIPAL INVESTIGATOR
Hongjae Chon
CHA Bundang Medical Center
- PRINCIPAL INVESTIGATOR
Niall Tebbutt
Austin Health
- PRINCIPAL INVESTIGATOR
Jung Hun Kang
Gyeongsang National University Hospital
- PRINCIPAL INVESTIGATOR
Seok Yun Kang
Ajou University School of Medicine
- PRINCIPAL INVESTIGATOR
Hyung Soon Park
Catholic University of Korea St. Vincent's Hospital
- PRINCIPAL INVESTIGATOR
Ji Hong Bae
Gachon Gil University Medical Center
- PRINCIPAL INVESTIGATOR
Cheol Kyung Sin
Ulsan University Hospital
- PRINCIPAL INVESTIGATOR
Hae Seong Park
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Thatcher Heumman
Vanderbilt-Ingram Cancer Center
- PRINCIPAL INVESTIGATOR
Hongsik Kim
Chungbuk National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
September 1, 2022
Study Start
August 26, 2022
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Beginning 1 year and ending 5 years after all trial endpoints were assessed
- Access Criteria
- Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr.
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to andrew90@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.