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| Name | Class |
|---|---|
| Suzhou Abogen Biosciences Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABO2102 | Experimental | Prat I: Monotherapy |
|
| ABO2102 and Toripalimab | Experimental | Part I&II: ABO2102 in combination with Toripalimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2102 | Drug | mRNA encoding mutant KRAS neoantigens, administrated intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab. | 21 days after the first dose of study treatment | |
| Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s. | from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy. | |
| Part I: The incidence and severity of serious TEAEs (TESAE)s. | from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy. | |
| Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment. | from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy. | |
| Part II: Overall Response Rate (ORR) per RECIST version 1.1. | from the first dose of study treatment to up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinjing Wang | Contact | 18817821319 | newvista89@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baiyong Shen | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab | Drug | Anti-PD-1 antibody, administered intravenously |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |