ClinicalTrials.gg
RecruitingNCT07763301Updated Aug 13, 2026

YMN-136 Vaccine for Patients With Advanced Hepatobiliary and Pancreatic Malignancies

A Phase 1 interventional study of YMN-136 vaccine in Liver Cancer, Pancreatic Cancer and Biliary Tract Cancer (BTC), sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by West China Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Liver Neoplasms by West China Hospital — 8 open to participants now, 8 under way, none of them phase 3. Liver Neoplasms · West China Hospital.

Started
2026
with 3 others
Phase 1
4 of 10
3 open now
Registered
10th of 10
by date

Among the 10 studies in Liver Neoplasms by West China Hospital, this one is one of 4 that started in 2026, is one of 4 in phase 1, and was the 10th registered.

Liver Neoplasms

1,346 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.

Browse Liver Neoplasms studies →

Open to participants now

8 of the 10 studies in Liver Neoplasms by West China Hospital are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 243 Liver Neoplasms studies recruiting now, 137 (56%) set no upper age limit and 69 (28%) stop at 75 or younger; 14 take children under 18; 34 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

This study aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with advanced hepatobiliary and pancreatic malignancies.

03

Conditions studied

  • Liver Cancer
  • Pancreatic Cancer
  • Biliary Tract Cancer (BTC)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Voluntarily sign the form, and be able to understand and agree to comply with the study procedures and visits as specified in the protocol.
  2. Age: 18 to 75 years old, male or female.
  3. Patients with or histologically confirmed, unresectable advanced hepatobiliary and pancreatic who must have experienced disease progression after receiving standard anti-tumor therapy, or who are unable to receive or tolerate standard therapy, or who refuse standard therapy:

(1) Patients with advanced hepatocellular carcinoma who have failed standard therapy, defined as disease progression after prior treatment with PD-(L)1 and mTKI systemic therapy (either separately or in combination), or discontinuation of treatment due to intolerance to toxicity; (2) Patients with advanced biliary tract cancer who have failed standard therapy, defined as disease progression after prior treatment with gemcitabine-containing systemic therapy and non-cytotoxic therapy (i.e., targeted therapy or immunotherapy), or discontinuation of treatment due to intolerance to toxicity; (3) Patients with advanced pancreatic cancer who have failed standard therapy, defined as disease progression after prior treatment with at least two systemic therapies (must include fluoropyrimidines and gemcitabine), or discontinuation of treatment due to intolerance to toxicity.

4. Positive IMP3 expression. 5. At least one evaluable lesion according to v1.1. 6. (ECOG) performance status: 0 or 1. 7. ≥ 12 weeks. 8. Organ function levels at screening must meet the following requirements:

  1. (ANC) ≥ 1.5 × 10⁹/L;
  2. count (PLT) ≥ 75 × 10⁹/L;
  3. (Hb) ≥ 90 g/L;
  4. Total (TBIL) ≤ 1.5 × ;
  5. (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in patients with liver ;
  6. Serum creatinine (Cr) ≤ 1.5 × ULN, or (Cockcroft-Gault formula) ≥ 45 mL/min;
  7. (INR) and prothrombin time (PT) ≤ 1.5 × ULN;
  8. calculated by Fridericia's formula ≤ 450 ms for males and ≤ 470 ms for females;
  9. Urinalysis/24-hour urine protein quantification: urine protein qualitative ≤ 1+ (if urine protein qualitative ≥ 2+, 24-hour urine protein \< 1 g is acceptable for enrollment);
  10. Cardiac function: ≥ 50%. 9. Eligible patients (male or female) with must agree to use a medically accepted physical method (e.g., intrauterine device, condom, tubal or vas deferens ligation, etc.) during the study period and for 6 months after the last dose. Female patients of childbearing potential must have a negative serum or urine HCG test at screening.

Exclusion criteria

Exclusion Criteria:

  1. Presence of extensive peritoneal or intestinal obstruction.
  2. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  3. Known allergy to any component of the drug (e.g., lipid nanoparticles, RNA carrier) or to drugs of the same class.
  4. Prior receipt of vaccine therapy.
  5. Received chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose.
  6. In the dose-escalation and dose-expansion phases: received anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biological therapy, or other investigational drug therapy for target lesions) within 4 weeks or 5 drug half-lives (whichever is shorter, but at least 14 days) prior to the first dose; or received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 14 days prior to the first dose.
  7. Use of drugs within 4 weeks prior to the first dose or expected use during the study period, except for nasal sprays, inhalers, or systemic prednisone ≤ 10 mg/day (or equivalent doses of similar drugs).
  8. History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
  9. Receipt of a within 28 days prior to the first dose.
  10. In the dose-escalation and dose-expansion phases: presence of symptomatic, untreated, or central nervous system (CNS) metastases requiring ongoing treatment (including corticosteroids and antiepileptics). Patients with previously treated may be enrolled if they have been clinically stable for at least 4 weeks prior to enrollment, have no evidence of new or enlarging metastases, and have discontinued corticosteroid therapy. Patients with asymptomatic CNS metastases not requiring treatment may be enrolled.
  11. In the dose-escalation and dose-expansion phases: toxicity from prior anti-tumor therapy that has not recovered to baseline or to Grade 0-1 per v5.0 (except for alopecia and hyperpigmentation). Irreversible toxicities that are reasonably not expected to be exacerbated by the study drug may be enrolled after confirmation with the investigator.
  12. History of diseases, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, rheumatoid arthritis, inflammatory bowel disease, etc. Patients with type I diabetes mellitus, hypothyroidism controlled with replacement therapy only, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) may be enrolled.
  13. History of immediate reactions, eczema, or asthma that cannot be controlled with topical corticosteroids.
  14. History of other , except for curatively treated curable tumors, such as basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
  15. Presence of uncontrolled comorbid conditions, including but not limited to: unexplained fever > 38.5°C (patients with tumor-related fever to be enrolled at the investigator's discretion); symptomatic congestive heart failure of (NYHA) class ≥ 2; (LVEF) \< 50%; poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after treatment, and assessed as by the investigator); unstable angina or acute myocardial infarction within 3 months prior to the first dose; poorly controlled arrhythmia; , asthma, or interstitial lung disease with impaired pulmonary function.
  16. Presence of active infection currently requiring systemic anti-infective therapy; patients with active tuberculosis.
  17. Known positive for (HIV) or active syphilis infection; and/or HBcAb positive with HBV-DNA > 500 IU/L; positive.
  18. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study, including but not limited to any disease or medical history that may confound the study results or interfere with patient compliance.
Terms in these criteria, in plain language(33)

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.

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.

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.

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.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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.

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.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    YMN-136 vaccine treatment

    Biological: YMN-136 vaccine

Interventions

  • BiologicalYMN-136 vaccine

    The YMN-136 vaccine will be administered according to the dose level assigned to each patient. Approximately every 3 weeks, the vaccine will be administered via intramuscular injection into the single upper arm, with 4 doses for prime immunization.

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Related Adverse Events

    Number of participants experiencing treatment-related adverse events, serious adverse events, dose-limiting toxicities, and adverse events leading to treatment discontinuation, graded according to NCI CTCAE v5.0

    Time frame: Approximately 24 months

Secondary outcomes

  1. Disease Control Rate (DCR)

    Proportion of participants achieving complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1

    Time frame: Approximately 24 months

  2. Objective Response Rate (ORR)

    Proportion of participants achieving complete response (CR), and partial response (PR) according to RECIST v1.1

    Time frame: Approximately 24 months

  3. Progression-Free Survival (PFS)

    Time from study enrollment to disease progression or death from any cause, whichever occurs first, according to RECIST v1.1

    Time frame: Approximately 24 months

  4. Overall Survival (OS)

    Time from study enrollment to death from any cause

    Time frame: Approximately 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Feb 2028, 18 months after the start.

Of 48 non-industry phase 1 interventional studies under Liver Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 63. This study's planned 18 months is below that.

Counting every sponsor, half of 99 studies reached it within 49 months; a quarter within 32 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 13, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Feb 29, 2028
CompletionEst.
May 31, 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763301
Responsible party
Dan Cao (Ph.D, West China Hospital) — Principal investigator
First posted
Aug 13, 2026
Start date
Aug 1, 2026
Primary completion
Feb 29, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Dan Cao, Dr.
Contact
caodan@scu.edu.cn
+8618980605963

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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