Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Regenelead Therapies Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose Escalation, Part B: Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab is a programmed death-ligand 1 antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| MTD/MAD | Maximum tolerated dose (MTD)/Maximum administrated dose (MAD) | From first dose up to end of the study, assessed up to 36 months |
| RDE | Recommended dose of expansion | From first dose up to end of the study, assessed up to 36 months |
| AE | Percentage of subjects with Adverse Events (AEs) | From date of ICF up to end of the study, assessed up to 36 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| mRNA tumor vaccines | Drug | neoantigen personalized mRNA vaccines |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |