Phase
Condition
Neoplasms
Treatment
intravenous (IV) infusion
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects who are informed of relevant information of the study prior toinitiation of the study and voluntarily sign and date on the informed consent form (ICF).
- Age ≥18 years. 3) Be willing to follow and be able to complete all the studyprocedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and bodyweight ≥45kg for female subjects.
5) Patients with histologically or cytologically confirmed locally advanced ormetastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC),renal cell carcinoma (RCC), endometrial cancer (EC), or other Napi2b-overexpressingtumors。 6) Patients with positive Napi2b test results at the central laboratory. 9)At least one radiologically evaluable lesion for subjects in Part 1; At least onemeasurable extracranial lesion (non-radiation fields) for subjects in Part 2 andPart 3.
Expected survival ≥3 months. 11) Female subjects of childbearing potential mustagree to take effective contraceptive measures and must not undergo egg donation oregg retrieval for their own use from screening throughout the study period and forat least 6 months after the last dose of the investigational drug. Male subjectsmust agree to take effective contraceptive measures and must not undergo spermcryopreservation or sperm donation from screening throughout the study period andfor at least 6 months after the last dose of the investigational drug.
subjects must provide tumor samples. 13) Subjects who are capable of and willingto comply with the visits and procedures stipulated in the study protocol.
Exclusion
Exclusion Criteria:
- Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with ahistory of intolerance to topoisomerase I inhibitors or ADC therapy.
Subjects who are participating in another clinical study, with the exception anof observational (non-interventional) clinical study or the follow-up period of aninterventional study.
Subjects with an insufficient washout period from the previous anti-tumor therapyto the first dose.
Subjects who received radiotherapy, including palliative stereotacticradiotherapy on the abdomen, within 4 weeks prior to the first dose.
Subjects who received major surgery within 4 weeks prior to the first dose orthose who plan to receive major surgery during the study.
Subjects who received allogeneic bone marrow transplantation or solid organtransplantation.
Subjects who received systemic steroids or other immunosuppressive treatmentwithin 2 weeks prior to the first dose of the investigational drug.
Subjects who received any live vaccine within 4 weeks prior to the first dose orthose who plan to receive live vaccines during the study.
Subjects with a medical history of leptomeningeal carcinoma or cancerousmeningitis.
Subjects with brain metastasis or spinal cord compression. 12) Subjects withuncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
Subjects who were diagnosed with Gilbert's syndrome. 14) Subjects withsignificantly symptomatic or unstable effusion in the third space requiring repeateddrainage.
Subjects with medical history of gastrointestinal perforation and/or fistulawithin 6 months prior to the first dose, or active gastric ulcers, duodenal ulcer,colitis ulcerative, or other gastrointestinal disorders that may cause hemorrhage orperforation in the opinion of the investigator.
Subjects with serious infection (Grade ≥3 as per NCI CTCAE v5.0) prior to thefirst dose.
Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV)or hepatitis C virus (HCV) infection; subjects with positive syphilis antibody and apositive titer result.
Subjects with unresolved toxicity caused by previous anti-tumor therapy. 20)Subjects with a history of serious allergic reactions to drugs, inactive ingredientsin drug products, or other monoclonal antibodies.
Female subjects who are pregnant as confirmed by a pregnancy test within 3 daysprior to the first dose, or lactating women.
Subjects who have any diseases, medical conditions, organ system dysfunction, orsocial conditions.
Subjects with multiple primary malignancies within 5 years prior to the signingof the ICF, except for fully resected non-melanoma skin cancer, radically treatedcarcinoma in situ, or other radically treated solid tumors.
Study Design
Connect with a study center
Fujian Provincial Cancer Hospital
Fuzhou 1810821, Fujian 1811017
ChinaActive - Recruiting
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou 1809858, Guangdong 1809935
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning 1799869, Guangxi 1809867
ChinaActive - Recruiting
Hainan General Hospital
Haikou 1809078, Hainan 1809054
ChinaActive - Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang 1795270, Hebei 1808773
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin 2037013, Heilongjiang 2036965
ChinaActive - Recruiting
Anyang Cancer Hospital
Anyang 1785294, Henan 1808520
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520
ChinaActive - Recruiting
Jingzhou First People's Hospital
Jingzhou 1805540, Hubei 1806949
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting
Tongji Medical College of Hust TongJi Hospital
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting
Union hospital Tongji Medical Colllege Huazhong University of School and Technology
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting
Zhongnan Hospital of Wuhan University
Wuhan 1791247, Hubei 1806949
ChinaActive - Recruiting
Hunan Provincial Cancer Hospital
Changsha 1815577, Hunan 1806691
ChinaActive - Recruiting
Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691
ChinaActive - Recruiting
Jilin Provincial Cancer Hospital
Changchun, Jilin
ChinaSite Not Available
Jilin Provincial Cancer Hospital
Changchun 2038180, Jilin 2036500
ChinaActive - Recruiting
Liaoning Cancer Hospital
Shenyang 2034937, Liaoning 2036115
ChinaActive - Recruiting
The People's Hospital of Liaoning Province
Shenyang 2034937, Liaoning 2036115
ChinaActive - Recruiting
Central Hospital Affiliated to Shandong First Medical University
Jinan 1805753, Shandong 1796328
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan 1805753, Shandong 1796328
ChinaActive - Recruiting
Shandong Cancer Hospital
Jinan 1805753, Shandong 1796328
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi 1803318, Shandong 1796328
ChinaActive - Recruiting
Shanxi Cancer Hospital
Taiyuan 1793511, Shanxi 1795912
ChinaActive - Recruiting
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an 11474004, Shanxi 1795912
ChinaActive - Recruiting
West China Second University Hospital, Sichuan University
Chengdu 1815286, Sichuan 1794299
ChinaActive - Recruiting
Yunnan Cancer Hospital
Kunming 1804651, Yunnan 1785694
ChinaActive - Recruiting
The First Affiliated Hospital. Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing 1816670,
ChinaActive - Recruiting
Chinese People's Liberation Army Army Characterstic Medical Center
Chongqing 1814906,
ChinaActive - Recruiting
Chongqing Cancer Hospital
Chongqing 1814906,
ChinaActive - Recruiting
The Southwest Hospital of AMU
Chongqing 1814906,
ChinaActive - Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai 1796236,
ChinaActive - Recruiting
Sarah Cannon Research Institute (SCRI)- Denver
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
Florida Cancer Specialists - Lake Mary
Lake Mary 4161373, Florida 4155751 32746
United StatesActive - Recruiting
Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40241
United StatesActive - Recruiting
Washington University School of Medicine - Center for advanced Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas 5506956, Nevada 5509151 89169
United StatesActive - Recruiting
Southwest Women's Oncology
Albuquerque 5454711, New Mexico 5481136 87109
United StatesActive - Recruiting
Stephenson Cancer Center (Oklahoma)
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesActive - Recruiting
Providence Cancer Institute - Franz Clinic
Portland 5746545, Oregon 5744337 97213
United StatesActive - Recruiting
Sarah Cannon Research (SCRI)-Tennessee
Nashville 11838957, Texas 4736286 37203
United StatesActive - Recruiting
University of Washington
Seattle 5809844, Washington 5815135 98915
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.