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| Name | Class |
|---|---|
| Abogen Biosciences (Shanghai) Co., Ltd | INDUSTRY |
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This is an open-label, single-arm, dose-escalation, and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABO2011 monotherapy or in combination with Toripalimab in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABO2011 | Experimental | Monotherapy |
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| ABO2011 and Toripalimab | Experimental | Combination therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO2011 Injection | Drug | Name of Active Ingredient: mRNA encoding human single-chain IL-12 protein; ABO2011 injection Route of administration: intratumoral injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Incidence and character of DLTs | monotherapy: 21 days after the first dose. Combination therapy: 28 days after the first dose] | |
| Phase I: Incidence of Adverse Event (AE) | monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration. | |
| Phase I: Incidence of Serious Adverse Event (SAE) | monotherapy: from informed consent until 28 days after the last administration. Combination therapy: from informed consent until 90 days after the last administration.] | |
| Phase I: Incidence of patients with clinically significant abnormal laboratory results | monotherapy: from the first dose until 28 days of last administration. Combination therapy: from informed consent until 90 days after the last administration. | |
| Phase II: Objective response rates | Estimated to be from time of informed consent up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nong Chen | Contact | 010-57593072 | nong.chen@abogenbio.com | |
| Shihui Fu | Contact | 010-57593072 | shihui.fu@abogenbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab | Drug | Anti-PD-1 antibody |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | China |
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| Shanxi Cancer hospital | Recruiting | Shanxi | China |
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| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Recruiting | Shenzhen | China |
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