Health TrialsbyHealthPanel

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

ConditionsLiver CancerPancreatic CancerBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;

Platelet count (PLT) ≥ 75 × 10⁹/L;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • YMN-136 vaccine

    Biological/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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: YMN-136 vaccine treatmentExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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