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Liver CancerPhase 1NCT07763301

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

A Phase 1 study testing YMN-136 vaccine in people with Liver Cancer and Pancreatic Cancer, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
YMN-136 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Aug 2026to 31 May 2028
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form, and be able to understand and agree to comply with the study procedures and visits as specified in the protocol.
  • Age: 18 to 75 years old, male or female.
  • Patients with pathologically or histologically confirmed, unresectable advanced hepatobiliary and pancreatic malignancies 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:
  • 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 RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. 7. Life expectancy ≥ 12 weeks. 8. Organ function levels at screening must meet the following requirements:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
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  • Platelet count (PLT) ≥ 75 × 10⁹/L;
  • Hemoglobin (Hb) ≥ 90 g/L;
  • Total bilirubin (TBIL) ≤ 1.5 × ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in patients with liver metastases;
  • Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (Cockcroft-Gault formula) ≥ 45 mL/min;
  • International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN;
  • QTc interval calculated by Fridericia's formula ≤ 450 ms for males and ≤ 470 ms for females;
  • 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);
  • Cardiac function: left ventricular ejection fraction ≥ 50%. 9. Eligible patients (male or female) with childbearing potential must agree to use a medically accepted physical contraceptive 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.

Who cannot join

  • Presence of extensive peritoneal metastasis or intestinal obstruction.
  • Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Known allergy to any component of the investigational drug (e.g., lipid nanoparticles, RNA carrier) or to drugs of the same class.
  • Prior receipt of vaccine therapy.
  • Received chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose.
  • 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.
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  • Use of immunosuppressive drugs within 4 weeks prior to the first dose or expected use during the study period, except for corticosteroid nasal sprays, inhalers, or systemic prednisone ≤ 10 mg/day (or equivalent doses of similar drugs).
  • History of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation.
  • Receipt of a live attenuated vaccine within 28 days prior to the first dose.
  • 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 CNS metastases 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.
  • 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 NCI-CTCAE 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.
  • History of autoimmune 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.
  • History of immediate hypersensitivity reactions, eczema, or asthma that cannot be controlled with topical corticosteroids.
  • History of other malignancies, 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.
  • 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 New York Heart Association (NYHA) class ≥ 2; left ventricular ejection fraction (LVEF) < 50%; poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after treatment, and assessed as clinically significant by the investigator); unstable angina or acute myocardial infarction within 3 months prior to the first dose; poorly controlled arrhythmia; chronic obstructive pulmonary disease, asthma, or interstitial lung disease with impaired pulmonary function.
  • Presence of active infection currently requiring systemic anti-infective therapy; patients with active tuberculosis.
  • Known positive for human immunodeficiency virus (HIV) or active syphilis infection; HBsAg and/or HBcAb positive with HBV-DNA > 500 IU/L; HCV-RNA positive.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dan Cao, Dr. contact

+8618980605963

caodan@scu.edu.cn

China1 site, 1 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Kexun Zhou, Dr., +028 85422589, kexunzhou@wchscu.cn

    Recruiting

Other trials in China

About this study

Official title: YMN-136 Vaccine for Patients With Advanced Hepatobiliary and Pancreatic Malignancies: A Prospective, Phase I Clinical Trial

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.

Being tested
YMN-136 vaccine
Medical subject headings
Liver Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YMN-136 vaccineBiological

    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.

Study groups in NCT07763301
Study groupRoleWhat they receive
YMN-136 vaccine treatmentExperimentalNot described
Receives: Biological: YMN-136 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Approximately 24 months

Secondary outcomes (4)

  1. Disease Control Rate (DCR)

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

    Measured: Approximately 24 months

  2. Objective Response Rate (ORR)

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

    Measured: 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

    Measured: Approximately 24 months

  4. Overall Survival (OS)

    Time from study enrollment to death from any cause

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start1 Aug 2026
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07763301
Sponsor's protocol ID
2026（1058）
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YMN-136 vaccine in people with Liver Cancer and Pancreatic Cancer, run by West China Hospital at 1 site in China.

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 15 inclusion and 18 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 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.

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 Dan Cao, Dr. (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Related Adverse Events (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07763301.

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 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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