NCT06913218

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Jul 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jul 2025Nov 2028

First Submitted

Initial submission to the registry

March 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2028

Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

March 30, 2025

Last Update Submit

March 30, 2025

Conditions

Pancreas CancerPancreas Cancer, Duct Cell Adenocarcinoma

Keywords

adjuvantpancreas cancermRNA

Outcome Measures

Primary Outcomes (2)

  • DLT

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

    Day 1 to Day 21 after the first tumour vaccine was administrated

  • AE

    Percentage of subjects with Adverse Events (AEs)

    From ICF up to 30days after last study treatment

Secondary Outcomes (2)

  • RFS

    2 years

  • OS

    2 years

Study Arms (1)

Pancreatic Cancer

EXPERIMENTAL

Resectable PDAC

Biological: AK154Biological: CadonilimabBiological: Ivonescimab (SMT112 or AK112) InjectionDrug: mFOLFORINOX

Interventions

AK154BIOLOGICAL

AK154 is neotigeon personalized mRNA vaccine

Pancreatic Cancer
CadonilimabBIOLOGICAL

a PD-1/CTLA-4 bispecific antibody

Pancreatic Cancer
Ivonescimab (SMT112 or AK112) InjectionBIOLOGICAL

a PD-1/VEGF bi-specific antibody

Pancreatic Cancer
mFOLFORINOXDRUG

mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

Pancreatic Cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ECOG 0 or 1
  • Life expectancy ≥ 6 months
  • Surgical complications have recovered,
  • Adequate organ function
  • Patients with fertility are willing to use an adequate method of contraception.

You may not qualify if:

  • 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
  • Severe infection occurs within 4 weeks prior to the first dose
  • Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration.
  • Acute pancreatitis or subclinical pancreatitis
  • Active autoimmune disease
  • Allergic to immunotherapies and related drugs
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Splenectomy history
  • Active tuberculosis
  • Known or highly suspected history of interstitial pneumonia.
  • Clinically significant liver disease
  • Uncontrolled or severe cardiovascular disease.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center

Shanghai, Xuhui, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Ting Liu

CONTACT

+86 (0760) 8987 3999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 6, 2025

Study Start

July 22, 2025

Primary Completion (Estimated)

February 23, 2028

Study Completion (Estimated)

November 6, 2028

Last Updated

April 6, 2025

Record last verified: 2025-03

Locations

CN(1)