PM8002 in the Treatment of Patients With Advanced Solid Tumors
NCT ID: NCT05918445
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
380 participants
INTERVENTIONAL
2021-03-09
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PM8002
PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)
PM8002
IV infusion
Interventions
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PM8002
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Male or female aged 18 to 75 years;
3. Patients with malignant tumor confirmed by histology or cytology;
4. The toxicity of previous anti-tumor therapy has not been alleviated；
5. Adequate organ function；
6. ECOG score was 0-1;
7. Expected survival \>=12 weeks;
8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.
Exclusion Criteria
2. Evidence of major coagulopathy or other obvious risk of bleeding;
3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;
5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
8. Syphilis antibody positive;
9. Patients with active tuberculosis (TB) are excluded;
10. Pregnant or lactating women;
11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.
18 Years
75 Years
ALL
No
Sponsors
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Biotheus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ye Guo
Role: PRINCIPAL_INVESTIGATOR
Shanghai Orient Hospital
Locations
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Baoji Central Hospital
Baoji, , China
Baoji Central Hospital
Baoji, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
Jilin Cancer Hospital
Changchun, , China
The First Hospital of Jilin University
Changchun, , China
Changde First People's Hospital
Changde, , China
Hunan Provincial People's Hospital
Changsha, , China
The First People's Hospital of Changzhou
Changzhou, , China
Chengdu Integrated TCM& Western Medicine Hospital
Chengdu, , China
Sichuan Cancer Hospital
Chengdu, , China
Chongqing Cancer Hospital
Chongqing, , China
Chongqing Cancer Hospital
Chongqing, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
The Southwest Hospital of AMU
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Fujian Cancer Hospital
Fuzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
Linyi Cancer Hospital
Linyi, , China
Jiangsu Province Hospital
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
Shanghai Orient Hospital
Shanghai, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Shengjing Hospital of China Medical University
Shengjing, , China
Liaoning Cancer Hospital
Shenyang, , China
The First Hospital of China Medical University
Shenyang, , China
The People's Hospital of Liaoning Province
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Bethune Hospital
Taiyuan, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Hubei Cancer Hospital
Wuhan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xi 'an International Medical Center Hospital
Xi'an, , China
Xi 'an International Medical Center Hospital
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
Yibin Second People's Hospital
Yibin, , China
Henan Cancer Hospital
Zhengzhou, , China
The first affilated hospital of zhengzhou university
Zhengzhou, , China
The first affilated hospital of zhengzhou university
Zhengzhou, , China
Zhujiang Hospital of Southern Medical University
Zhujiang, , China
Countries
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Central Contacts
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Facility Contacts
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Yaning Zhao
Role: primary
Gang Wang
Role: primary
Lingying Wu
Role: primary
Jun Guo
Role: primary
Lin Shen
Role: primary
Yng Cheng
Role: primary
Jiuwei Cui
Role: primary
Tao Wu
Role: primary
Huaxin Duan
Role: primary
Mei Ji
Role: primary
Ping Li
Role: primary
Yongdong Jin
Role: primary
Yongsheng Li
Role: primary
Hong Luo
Role: primary
Chengyou Du
Role: primary
Zhiqing Liang
Role: primary
An Lin
Role: primary
Yu Chen
Role: primary
Zhiquan Qin
Role: primary
Baogang Liu
Role: primary
Yueyin pan
Role: primary
Jingfen Wang
Role: primary
Yongmei Yin
Role: primary
Zengjun Wang
Role: primary
Ye Guo
Role: primary
Hun Zhao
Role: primary
Bin Wu
Role: primary
Chunyan Wang
Role: primary
Funan Liu
Role: primary
Lijie He
Role: primary
Da Jiang
Role: primary
Huijing Feng
Role: primary
Yusheng Wang
Role: primary
Shuqing Wei
Role: primary
Dongqing Lv
Role: primary
Gang Li
Role: primary
Feng Zhang
Role: primary
Yi Huang
Role: primary
Guiling Li
Role: primary
Ruifang An
Role: primary
Xinpeng Han
Role: primary
Kejun Nan
Role: primary
Jitao Wu
Role: primary
Kaijian Lei
Role: primary
Suxia Luo
Role: primary
Yanru Qin
Role: primary
Xingya Li
Role: primary
Jian Zhang
Role: primary
Other Identifiers
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PM8002-A001
Identifier Type: -
Identifier Source: org_study_id