Clinical trial NCT06913218: A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
Official title: An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pancreas Cancer
Pancreas Cancer, Duct Cell Adenocarcinoma
Keywords: adjuvant
pancreas cancer
mRNA
Lead sponsor: Akeso
Sponsor class: INDUSTRY
Collaborators: name: Fudan University Shanghai Cancer Center ( FUSCC )
First posted: 2025-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Severe bleeding tendency or history of coagulopathy
* Active malignancy within the last 3 years
* Active syphilis infection
* Any other situations that are not suitable for inclusion in this study judged by investigator.

Primary outcomes:
measure: DLT
timeFrame: Day 1 to Day 21 after the first tumour vaccine was administrated
measure: AE
timeFrame: From ICF up to 30days after last study treatment
Secondary outcomes:
measure: RFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
state: Xuhui
Study officials:
References: