A Phase 1/2 interventional study of YH32364 in EGFR Overexpression, Locally Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Yuhan Corporation. Recruiting at 4 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Yuhan Corporation · Phase 1/2, Interventional, and Treatment
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.
YH32364 is a new type of immunotherapy called a bispecific antibody that targets both Epidermal Growth Factor Receptor (EGFR) and 4-1BB. EGFR is a gene involved in cancer growth, and many cancer treatments aim to target it. 4-1BB, an immune-modulating protein, plays an important role in boosting T cell activity to combat cancer.
YH32364 is a treatment designed to activate 4-1BB specifically in tumors, aiming to avoid the liver-related side effects seen with previous 4-1BB treatments. It also helps block EGFR signals, assumed to make EGFR-targeted therapies more effective by overcoming resistance.
This study is consists of two parts. In Part 1, participants will be assigned sequentially to one of six dose levels, ranging from the lowest to the highest dose as determined by the sponsor, in order to identify an appropriate dosage.
In Part 2, participants will be randomly assigned to one of the two optimal dose levels identified in Part 1 to confirm the recommended dose.
The YH32364 will be administered via intravenous (IV) infusion once every two weeks. Participants will be required to visit the study site regularly for treatment and assessments. During all the visits, the doctors check participants' health and take note of any unwanted effects.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Yuhan Corporation is the lead sponsor of 110 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
[Dose Escalation Only] Locally advanced or EGFR overexpressing solid tumor* that is or intolerable on all available standard therapy and that is considered uncurable by local therapy
* One of the following confirmed EGFR overexpressing (IHC3+ or IHC2+) tumors.
[Dose Expansion Only] Cohort 1: Pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+), locally advanced or metastatic HNSCC other than nasopharyngeal carcinoma (NPC)* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy.
Exclusion Criteria:
Have history of a second primary cancer with the exception of
[Prior/Concomitant Therapy]
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose Escalation Part: Dose Escalation part is designed to assess the safety and tolerability of YH32364 and to identify the Maximum Tolerated dose (MTD) and/or two dose levels for recommended dose (RD) selection. Dose Expansion Part: Dose Expansion part will consist of multiple cohorts by cancer types. Cohort 1 will be initiated to determine the RD after completion of Part 1. The RD will be determined among two dose levels investigated in Cohort 1 based on the totality of available data including PK, biomarkers, dose-response, safety, and efficacy.
Drug: YH32364
Dose Escalation Part: In this part, 6 dose levels are planned and approximately 30 patients will be enrolled. After each dose level, Safety Review Committee (SRC) will evaluate the available safety, tolerability, PK of YH32364 to decide the next dose. Dose Expansion Part: 50 participants with previously treated locally advanced or metastatic EGFR overexpressing HNSCC other than NPC will be randomized 1:1 ratio to each dose. (Cohort 1: Participants with locally advanced or metastatic EGFR overexpressing HNSCC other than NPC, whose disease progressed after or who are intolerable to all the available standard treatment)
Treatment-emergent adverse events (TEAEs) including dose limiting toxicities (DLTs)
To assess the safety and tolerability of YH32364 in order to determine maximum tolerated dose (MTD) and select doses for dose optimization
Time frame: Study Day 1 to Study Day 28 (during the DLTs evaluation period)
Objective Response Rate (ORR)
To assess the ORR of YH32364 at the recommended dose (RD) according to RECIST v1.1 by Investigator assessment
Time frame: through dose expansion part completion, approximately 1.5 year
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
AUC from time 0 to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Maximum observed serum concentration (Cmax)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Time to reach Cmax (Tmax)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Apparent terminal elimination half-life (t1/2)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Total clearance (CL)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Volume of distribution (Vd)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Volume of distribution at steady state (Vss)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
AUC during dosing interval at steady state (AUCtau)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Cmax at steady state (Cmax,ss)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Time to reach Cmax,ss (Tmax,ss)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Accumulation ratio (Rac)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Trough (predose) serum concentration on Cycle 4 (Ctrough)
To characterize the pharmacokinetics (PK) of YH32364
Time frame: through study completion, approximately 2.5 year
Presence and characterization of YH32364 ADA including neutralizing antibodies
To explore the immunogenicity of YH32364
Time frame: through study completion, approximately 2.5 year
Titer of YH32364 ADA
To explore the immunogenicity of YH32364
Time frame: through study completion, approximately 2.5 year
Objective Response Rate (ORR)
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through dose escalation part completion, approximately 1 year
Duration of Response (DoR)
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Disease Control Rate (DCR)
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Depth of Response
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Time to Response
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Progression-free survival (PFS)
To assess the anti-tumor activity according to RECIST v1.1 by Investigator assessment
Time frame: through study completion, approximately 2.5 year
TEAEs
To assess the safety and tolerability of YH32364
Time frame: through dose expansion part completion, approximately 1.5 year
Overall Survival (OS)
To assess the overall survival of YH32364 at the RD
Time frame: through dose expansion part completion, approximately 1.5 year
Immune ORR (iORR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Immune Duration of Response (iDOR)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Immune PFS (iPFS)
To assess the immune-related efficacy according to iRECIST by Investigator assessment
Time frame: through study completion, approximately 2.5 year
Plan to share: 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 clinicaltrials@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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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 clinicaltrials@yuhan.co.kr
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.
Of 127 industry-sponsored phase 1/2 interventional studies under Neoplasm Metastasis, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's planned 24 months is below that.
Counting every sponsor, half of 213 studies reached it within 62 months; a quarter within 41 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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