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| Name | Class |
|---|---|
| Abogen Biosciences (Shanghai) Co., Ltd | INDUSTRY |
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This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABO2102 Injection | Experimental | Monotherapy |
|
| ABO2102 Injection and Sintilimab Injection | Experimental | ABO2102 Injection in combination with Sintilimab Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2102 Injection | Drug | mRNA encoding mutant KRAS neoantigens, administrated intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab | 28 days after the first dose of study treatment | |
| Part I: Incidence and severity of adverse events | 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: ORR evaluated by investigators according to RECIST v1.1 criteria | from the first dose of study treatment to up to 3 years | |
| Part II: PFS evaluated by investigators according to RECIST v1.1 criteria | from the first dose of study treatment to up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Zhang | Contact | 8619931100148 | xiao.zhang@abogenbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Sintilimab injection | Drug | Anti-PD-1 antibody, administered intravenously |
|