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NCT05918445

PM8002 en el tratamiento de pacientes con tumores sólidos avanzados.

Reclutando Fase 1

Descripción

Este estudio tiene como objetivo caracterizar la seguridad, la tolerabilidad, la farmacocinética (PK), la inmunogenicidad, la farmacodinámica (PD) y la actividad antitumoral de PM8002, un anticuerpo bispecífico PD-L1/VEGF, cuando se administra como agente único en pacientes adultos con tumores sólidos avanzados.

Criterios de Elegibilidad

Inclusion Criteria:

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;

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:

1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;

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.

Información del Ensayo

NCT05918445
Reclutando
Fase 1
380 participantes
Mar 2021
Nov 2025

Ubicaciones48

China (48)
Baoji Central Hospital
Baoji Reclutando
Baoji Central Hospital
Baoji Reclutando
Cancer Hospital Chinese Academy of Medical Sciences
Beijing Reclutando
Peking University Cancer Hospital
Beijing Reclutando
Peking University Cancer Hospital
Beijing Reclutando
Jilin Cancer Hospital
Changchun Reclutando
The First Hospital of Jilin University
Changchun Reclutando
Changde First People's Hospital
Changde Reclutando
Hunan Provincial People's Hospital
Changsha Reclutando
The First People's Hospital of Changzhou
Changzhou Reclutando
Chengdu Integrated TCM& Western Medicine Hospital
Chengdu Reclutando
Sichuan Cancer Hospital
Chengdu Reclutando
Chongqing Cancer Hospital
Chongqing Reclutando
Chongqing Cancer Hospital
Chongqing Reclutando
The First Affiliated Hospital of Chongqing Medical University
Chongqing Reclutando
The Southwest Hospital of AMU
Chongqing Reclutando
Fujian Cancer Hospital
Fuzhou Reclutando
Fujian Cancer Hospital
Fuzhou Reclutando
Zhejiang Provincial People's Hospital
Hangzhou Reclutando
Harbin Medical University Cancer Hospital
Harbin Reclutando
Anhui Provincial Hospital
Hefei Reclutando
Linyi Cancer Hospital
Linyi Reclutando
Jiangsu Province Hospital
Nanjing Reclutando
Jiangsu Province Hospital
Nanjing Reclutando
Shanghai Orient Hospital
Shanghai Reclutando
Shanghai Sixth People's Hospital
Shanghai Reclutando
Shengjing Hospital of China Medical University
Shengjing Reclutando
Liaoning Cancer Hospital
Shenyang Reclutando
The First Hospital of China Medical University
Shenyang Reclutando
The People's Hospital of Liaoning Province
Shenyang Reclutando
The Fourth Hospital of Hebei Medical University
Shijiazhuang Reclutando
Shanxi Bethune Hospital
Taiyuan Reclutando
Shanxi Provincial Cancer Hospital
Taiyuan Reclutando
Shanxi Provincial Cancer Hospital
Taiyuan Reclutando
Taizhou Hospital of Zhejiang Province
Taizhou Reclutando
The Second Hospital of Tianjin Medical University
Tianjin Reclutando
Hubei Cancer Hospital
Wuhan Reclutando
Hubei Cancer Hospital
Wuhan Reclutando
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Reclutando
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Reclutando
Xi 'an International Medical Center Hospital
Xi'an Reclutando
Xi 'an International Medical Center Hospital
Xi'an Reclutando
Yantai Yuhuangding Hospital
Yantai Reclutando
Yibin Second People's Hospital
Yibin Reclutando
Henan Cancer Hospital
Zhengzhou Reclutando
The first affilated hospital of zhengzhou university
Zhengzhou Reclutando
The first affilated hospital of zhengzhou university
Zhengzhou Reclutando
Zhujiang Hospital of Southern Medical University
Zhujiang Reclutando