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Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.
The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human single chain IL-12 mRNA-single dose | Experimental | Human single chain IL-12 mRNA-single dose |
|
| Human single chain IL-12 mRNA-multiple dose | Experimental | Human single chain IL-12 mRNA-multiple dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human single chain IL-12 mRNA-single dose | Biological | human single chain IL-12 mRNA administered as specified in the treatment arm with injection once only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing dose-limiting toxicities (DLTs) | Number of Participants Experiencing dose-limiting toxicities (DLTs) | From first dose to Day 28 |
| Number of Participants Experiencing Adverse Events (AEs) | Number of Participants Experiencing Adverse Events (AEs) | From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months |
| Number of Participants Experiencing Severe Adverse Events (SAEs) | Number of Participants Experiencing Severe Adverse Events (SAEs) | From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (ORR) | Up to 36 months |
| Disease Control Rate(DCR) | Disease Control Rate(DCR) | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Wu, Doctor | Contact | +8610 87788495 | wumingshi-117@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, Doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| human single chain IL-12 mRNA-multiple dose | Biological | human single chain IL-12 mRNA administered as specified in the treatment arm with injection once per week for 3 weeks |
|
| Duration of Response (DOR) | Duration of Response (DOR) | Up to 36 months |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) | Up to 36 months |
| Overall Survival | Overall Survival | Up to 36 months |
| Maximum observed concentration (Cmax) of ABOD2011 | Maximum observed concentration (Cmax) of ABOD2011 | From first dose of ABOD2011 through to 28 days after last dose of investigational product |
| Area under the concentration-time curve (AUC) of ABOD2011 | Area under the concentration-time curve (AUC) of ABOD2011 | From first dose of ABOD2011 through to 28 days after last dose of investigational product |
| Maximum observed concentration (Cmax) of IL-12 | Maximum observed concentration (Cmax) of IL-12 | From first dose of ABOD2011 through to 28 days after last dose of investigational product |
| Area under the concentration-time curve (AUC) of IL-12 | Area under the concentration-time curve (AUC) of IL-12 | From first dose of ABOD2011 through to 28 days after last dose of investigational product. |
| Plasma concentration of IFN gamma | Plasma concentration of IFN gamma | From first dose of ABOD2011 through to 28 days after last dose of investigational product. |