Pancreas CancerPhase 1NCT06913218
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
A Phase 1 study testing AK154, Cadonilimab and Ivonescimab (SMT112 or AK112) Injection in people with Pancreas Cancer and Pancreas Cancer, Duct Cell Adenocarcinoma, run by Akeso at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma
- What is being tested?
- AK154, Cadonilimab and Ivonescimab (SMT112 or AK112) Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2025to 6 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Surgical complications have recovered,
- Adequate organ function
- Patients with fertility are willing to use an adequate method of contraception.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
Shanghai, Xuhui, 200032
Xianjun Yu, PhD,MD, 021-33988888, fuscc_gjswb@163.com
About this study
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
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
Read the 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
- Being tested
- AK154, Cadonilimab, Ivonescimab (SMT112 or AK112) Injection, mFOLFORINOX
- Keywords
- adjuvant, pancreas cancer, mRNA
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK154Biological
AK154 is neotigeon personalized mRNA vaccine
CadonilimabBiological
a PD-1/CTLA-4 bispecific antibody
Ivonescimab (SMT112 or AK112) InjectionBiological
a PD-1/VEGF bi-specific antibody
mFOLFORINOXDrug
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer | Experimental | Resectable PDAC Receives: Biological: AK154; Biological: Cadonilimab; Biological: Ivonescimab (SMT112 or AK112) Injection; Drug: mFOLFORINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Percentage of subjects who meet the criteria of DLT in DLT observation period
Measured: Day 1 to Day 21 after the first tumour vaccine was administrated
AE
Percentage of subjects with Adverse Events (AEs)
Measured: From ICF up to 30days after last study treatment
Secondary outcomes (2)
RFS
Recurrence free survival（RFS）
Measured: 2 years
OS
Overall survival（OS）
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start22 Jul 2025 (estimated)
- Primary completion23 Feb 2028 (estimated)
- Study completion6 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913218
- Sponsor's protocol ID
- AK154-IIT-001
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06913218
- Acronym / sponsor ID
- AK154-IIT-001
- Keywords
- adjuvant, pancreas cancer, mRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 22 Jul 2025 (estimated)
- Primary completion
- 23 Feb 2028 (estimated)
- Study completion
- 6 Nov 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer | Experimental | Biological: AK154, Biological: Cadonilimab, Biological: Ivonescimab (SMT112 or AK112) Injection, Drug: mFOLFORINOXResectable PDAC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK154AK154 is neotigeon personalized mRNA vaccine | Biological | Pancreatic Cancer |
| Cadonilimaba PD-1/CTLA-4 bispecific antibody | Biological | Pancreatic Cancer |
| Ivonescimab (SMT112 or AK112) Injectiona PD-1/VEGF bi-specific antibody | Biological | Pancreatic Cancer |
| mFOLFORINOXmFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin | Drug | Pancreatic Cancer |
Primary outcome
DLT
Time frame: Day 1 to Day 21 after the first tumour vaccine was administrated
Percentage of subjects who meet the criteria of DLT in DLT observation period
AE
Time frame: From ICF up to 30days after last study treatment
Percentage of subjects with Adverse Events (AEs)
2 secondary outcomes
RFS
Time frame: 2 years
OS
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK154, Cadonilimab and Ivonescimab (SMT112 or AK112) Injection in people with Pancreas Cancer and Pancreas Cancer, Duct Cell Adenocarcinoma, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Liu (+86 (0760) 8987 3999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Day 1 to Day 21 after the first tumour vaccine was administrated). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.