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This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PM8002 | Experimental | PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM8002 | Drug | IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with DLTs | DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment. | During the first three weeks of treatment with PM8002 |
| Treatment related adverse events (TRAEs) | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 | Up to 30 days after last treatment |
| Objective response rate (ORR) | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. | Up to approximately 2 years |
| Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1). for subjects with no documented disease progression, the deadline is the data of the last examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Guo | Contact | 135 0167 8472 | pattrickguo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Guo | Shanghai Orient Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoji Central Hospital | Recruiting | Baoji | China |
The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
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After the trial completed
NCI is committed to sharing data in accordance with NIH policy.
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| Up to approximately 2 years |
| Overall survival (OS) | OS is the time from the date of first dosing date to death due to any cause. | Up to approximately 2 years |
| Progression-free survival (PFS) | Progression-free survival is defined as the time from the start of treatment with PM8002 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Anti-drug antibody (ADA) | To evaluate the incidence of ADA to PM8002. | Up to 30 days after last treatment |
| Baoji Central Hospital | Recruiting | Baoji | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| Peking University Cancer Hospital | Recruiting | Beijing | China |
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| Peking University Cancer Hospital | Recruiting | Beijing | China |
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| Jilin Cancer Hospital | Recruiting | Changchun | China |
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| The First Hospital of Jilin University | Recruiting | Changchun | China |
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| Changde First People's Hospital | Recruiting | Changde | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | China |
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| The First People's Hospital of Changzhou | Recruiting | Changzhou | China |
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| Chengdu Integrated TCM& Western Medicine Hospital | Recruiting | Chengdu | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | China |
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| Chongqing Cancer Hospital | Recruiting | Chongqing | China |
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| Chongqing Cancer Hospital | Recruiting | Chongqing | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| The Southwest Hospital of AMU | Recruiting | Chongqing | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | China |
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| Anhui Provincial Hospital | Recruiting | Hefei | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | China |
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| Shanghai Orient Hospital | Recruiting | Shanghai | China |
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| Shanghai Sixth People's Hospital | Recruiting | Shanghai | China |
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| Shengjing Hospital of China Medical University | Recruiting | Shengjing | China |
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| Liaoning Cancer Hospital | Recruiting | Shenyang | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | China |
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| The People's Hospital of Liaoning Province | Recruiting | Shenyang | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | China |
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| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | China |
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| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | China |
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| The Second Hospital of Tianjin Medical University | Recruiting | Tianjin | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | China |
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| Xi 'an International Medical Center Hospital | Recruiting | Xi'an | China |
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| Xi 'an International Medical Center Hospital | Recruiting | Xi'an | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | China |
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| Yibin Second People's Hospital | Recruiting | Yibin | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
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| The first affilated hospital of zhengzhou university | Recruiting | Zhengzhou | China |
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| The first affilated hospital of zhengzhou university | Recruiting | Zhengzhou | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Zhujiang | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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