HER2-Positive Solid TumorPhase 1/2NCT05523947
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
A Phase 1/2 study testing YH32367 in people with HER2-Positive Solid Tumor, run by Yuhan Corporation at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-Positive Solid Tumor
- What is being tested?
- YH32367
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 26 Aug 2022to 30 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [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
Who cannot join
- Uncontrolled central nervous system (CNS) metastases
- Spinal cord compression
- Carcinomatous meningitis
- Acute coronary syndromes
- Heart failure
- Interstitial lung disease (ILD)
Show all 13Show fewer
- Pneumonitis
- History of a second primary cancer
- Human immunodeficiency virus (HIV)
- Active chronic hepatitis B
- Hepatitis C
- Systemic steroid therapy
- Autoimmune disease
Trial locations and contacts
19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 3 countries
South Korea13 sites, 13 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
- Recruiting
Gachon Gil University Medical Center
Incheon, 21565
- Recruiting
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, St. Mary's hospital
Seoul, 06591
- Recruiting
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
- Recruiting
Ulsan University Hospital
Ulsan, 44437
Australia4 sites, 1 recruiting
- Terminated
Southern Oncology Clinical Research Unit
Adelaide
- Withdrawn
Austin Health
Melbourne
- Withdrawn
Breast Cancer Research Centre - WA
Perth
- Recruiting
Blacktown Hospital
Sydney
United States2 sites, 1 recruiting
- Withdrawn
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
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
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.
Read the 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.
- Conditions
- HER2-Positive Solid Tumor
- Being tested
- YH32367
- Keywords
- YH32367, HER2/4-1BB bispecific antibody, Solid tumor, Breast cancer, Gastric cancer, HER2-positive, Biliary tract cancer
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH32367Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| YH32367 | Experimental | Dose 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). Receives: Drug: YH32367 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) up to Day 21
To assess the safety and tolerability of YH32367
Measured: 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)
Measured: 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)
To characterize the PK of YH32367
Measured: up to 66 weeks
maximum observed serum concentration (Cmax)
To characterize the PK of YH32367
Measured: up to 66 weeks
time to reach Cmax (Tmax)
To characterize the PK of YH32367
Measured: up to 66 weeks
Presence and characterization of YH32367 ADA in serum including titer of ADA and neutralizing antibodies
To explore the immunogenicity of YH32367
Measured: through study completion, approximately 3.5 year
Objective Response Rate (ORR)
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
Duration of Response (DoR)
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
Disease Control Rate (DCR)
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
Depth of Response
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
Time to Response
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
Progression-free survival (PFS)
To assess the anti-tumor efficacy according to RECIST v1.1 by Investigator assessment
Measured: through study completion, approximately 3.5 year
TEAEs
To assess the safety and tolerability of YH32367 at the RP2D
Measured: through dose expansion part completion, approximately 2.5 year
Overall Survival (OS)
To assess overall survival of YH32367
Measured: through study completion, approximately 3.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start26 Aug 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Positive Solid TumorStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyejin Choi, Principal investigator, Severance HospitalKyu-pyo Kim, Principal investigator, Asan Medical CenterDo-Youn Oh, Principal investigator, Seoul National University HospitalJoon Oh Park, Principal investigator, Samsung Medical CenterGanessan Kichenadasse, Principal investigator, Southern Oncology Clinical Research UnitJennifer Man, Principal investigator, Blacktown HospitalArlene Chan, Principal investigator, Breast Cancer Research Centre WAJu Won Kim, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523947
- Sponsor's protocol ID
- YH32367-101
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05523947
- Acronym / sponsor ID
- YH32367-101
- Conditions
- HER2-Positive Solid Tumor
- Keywords
- YH32367, HER2/4-1BB bispecific antibody, Solid tumor, Breast cancer, Gastric cancer, HER2-positive, Biliary tract cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YH32367 | Experimental | Drug: YH32367Dose 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- [Dose Escalation Part]
- Pathologically confirmed HER2-positive
- Mandatory provision of tumor tissue sample
- [Dose Expansion Part]
- Patients who have at least one measurable lesion
Key exclusion criteria (13 listed)
- Uncontrolled central nervous system (CNS) metastases
- Spinal cord compression
- Carcinomatous meningitis
- Acute coronary syndromes
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH32367Dose 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. | Drug | YH32367 |
Primary outcome
Treatment-emergent adverse events (TEAEs) up to Day 21
Time frame: in dose escalation part, an average of 21 days
To assess the safety and tolerability of YH32367
Objective Response Rate (ORR)
Time frame: through dose expansion part completion, approximately 2.5 year
To assess the ORR of YH32367 at the recommended Phase 2 dose (RP2D) according to RECIST v1.1 by blinded independent central reviews (BICR)
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyejin Choi principal investigator
Severance Hospital
Kyu-pyo Kim principal investigator
Asan Medical Center
Do-Youn Oh principal investigator
Seoul National University Hospital
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YH32367 in people with HER2-Positive Solid Tumor, run by Yuhan Corporation at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operation Team 1 (+82-2-828-0065, clinicaltrials@yuhan.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) up to Day 21 (time frame: in dose escalation part, an average of 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.