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

Akeso

Status and phase: Not yet enrolling; Phase 1

Conditions: Pancreas Cancer; Pancreas Cancer, Duct Cell Adenocarcinoma

Treatments: Biological: AK154; Biological: Cadonilimab; Biological: Ivonescimab (SMT112 or AK112) Injection; Drug: mFOLFORINOX

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06913218

AK154-IIT-001

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Pancreatic Cancer

Experimental group

Description:

Resectable PDAC

Treatment:

Drug: mFOLFORINOX

Biological: Ivonescimab (SMT112 or AK112) Injection

Biological: Cadonilimab

Biological: AK154