A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOL… (NCT06913218) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
China60 participantsStarted 2025-07-22
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Cl…
What they're measuring
1
DLT
Timeframe: Day 1 to Day 21 after the first tumour vaccine was administrated
2
AE
Timeframe: From ICF up to 30days after last study treatment