Health TrialsbyHealthPanel

A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC

ConditionsPancreas CancerPancreas Cancer, Duct Cell Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed the informed consent form and complied with protocols requirements

Patients with radiographically resectable primary pancreatic tumors

Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1)

Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0

Disqualifiers

The presence of other pathologic types

Participating in another clinical study

Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc

Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • AK154

    Biological/Vaccine

    AK154 is neotigeon personalized mRNA vaccine

  • Cadonilimab

    Biological/Vaccine

    a PD-1/CTLA-4 bispecific antibody

  • Ivonescimab (SMT112 or AK112) Injection

    Biological/Vaccine

    a PD-1/VEGF bi-specific antibody

  • mFOLFORINOX

    Drug

    mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Pancreatic CancerExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

DLT

Percentage of subjects who meet the criteria of DLT in DLT observation period

Time frame
Day 1 to Day 21 after the first tumour vaccine was administrated
2

AE

Percentage of subjects with Adverse Events (AEs)

Time frame
From ICF up to 30days after last study treatment

Secondary outcomes

1

RFS

Recurrence free survival（RFS）

Time frame
2 years
2

OS

Overall survival（OS）

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Akeso

Lead sponsor

Fudan University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: