Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

Pancreatic Cancer Clinical Trial

Official title:

An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156267
• Other study ID #: PANC-IIT-RGL-mRNA vaccine
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 2024
• Est. completion date: March 2027

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Voluntarily signed the informed consent form and complied with protocols requirements.

2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).

3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.

4. Tumour specimen availability.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

6. Life expectancy = 6 months.

7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.

8. Adequate marrow and organ function.

9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria:

1. Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.

2. Unsuitable for immunotherapy assessed by the investigator.

3. 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.

4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.

5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.

6. Known or highly suspected history of interstitial pneumonia.

7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.

8. Prior malignancy within 5 years prior to study entry.

9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

10. Known splenectomy history.

11. Concurrent severe infection within 28 days prior to initiation of study treatment.

12. Congenital or acquired immune deficiency.

13. Active hepatitis B (HBV-DNA=1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).

14. Uncontrolled or severe cardiovascular disease.

15. Other situations that are not suitable for inclusion in this study judged by investigator.

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Drug:
• Adebrelimab
Adebrelimab is a programmed death-ligand 1 antibody.
• mRNA tumor vaccines
neoantigen personalized mRNA vaccines

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Shanghai Regenelead Therapies Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT	Percentage of subjects who meet the criteria of DLT in DLT observation period	Day 1 to Day 28 after the first tumour vaccine was administrated
Primary	MTD/MAD	Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)	From first dose up to end of the study, assessed up to 36 months
Primary	RDE	Recommended dose of expansion	From first dose up to end of the study, assessed up to 36 months
Primary	AE	Percentage of subjects with Adverse Events (AEs)	From date of ICF up to end of the study, assessed up to 36 months