Phase
Condition
Neoplasms
Neuroblastoma
Treatment
Pembrolizumab
SKB264
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
Subjects with expected survival ≥ 3 months.
Cohort A: Subjects with recurrent or metastatic cervical cancer
Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
Cohort C: Subjects with recurrent ovarian cancer
Cohort D: Subjects with metastatic prostate cancer
Subjects have at least one measurable lesion per Response Evaluation Criteria inSolid Tumors (RECIST) 1.1 criteria.
Subjects able to provide tumor blocks or slides for biomarker test.
Subjects have relatively good organ function and bone marrow function.
Subjects must have recovered from all toxicities from previous therapy with theexception of toxicities not considered a safety risk.
Contraceptive use by men and women must be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.
Subject is capable of giving signed informed consent.
Cohort E: Subjects with advanced endometrial cancer.
Exclusion
Exclusion Criteria:
Subjects with active or untreated central nervous system (CNS) metastases and/orcarcinomatous meningitis are not eligible.
Subjects who suffer from cardiovascular diseases of clinical significance.
Subjects with serious and/or uncontrolled concomitant diseases.
Subjects diagnosed active hepatitis B or hepatitis C.
Subjects have known human immunodeficiency virus (HIV) infection that is not wellcontrolled.
Subjects with known active tuberculosis.
Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients ofpembrolizumab or SKB264.
Subjects with history of allogeneic tissue/solid organ transplant.
Subjects previously treated with TROP2 targeted therapy.
Subjects who are vaccinated with live vaccine within 30 days before the first dose,or plan to be vaccinated with live vaccine during the study period.
Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
The Investigator considers other situations that will interfere with the evaluationof the study intervention or the safety of the subjects or the interpretation of theresults of the study.
Study Design
Connect with a study center
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park,
AustraliaActive - Recruiting
Wollongong Hospital
Kogarah,
AustraliaActive - Recruiting
Algemeen Ziekenhuis Klina
Brasschaat,
BelgiumActive - Recruiting
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi,
BelgiumActive - Recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert,
BelgiumActive - Recruiting
BC Cancer - Kelowna
Kelowna, British Columbia V1Y5L3
CanadaActive - Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal,
CanadaActive - Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun, Jinlin
ChinaActive - Recruiting
The Second Hospital of Dalian
Dalian, Liaoning
ChinaActive - Recruiting
Weifang People's Hospital
Weifang, Shandong
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi
ChinaActive - Recruiting
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
Peking University First Hospital
Beijing,
ChinaActive - Recruiting
The First Affiliated Hospital of Jilin University
Changchun,
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha,
ChinaActive - Recruiting
Chongqing Cancer Hospital
Chongqing,
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou,
ChinaActive - Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou,
ChinaActive - Recruiting
Qilu Hosptial of Qlilu University
Jinan,
ChinaActive - Recruiting
Shandong Cancer Hospital
Jinan,
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing,
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai,
ChinaActive - Recruiting
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Shanghai,
ChinaActive - Recruiting
Liaoning Cancer Hospital & Institute
Shenyang,
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou,
ChinaActive - Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan,
ChinaActive - Recruiting
Zhongnan Hospital of Wuhan University
Wuhan,
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou,
ChinaActive - Recruiting
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
Zhengzhou,
ChinaActive - Recruiting
The first Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaActive - Recruiting
Szpitale Pomorskie Sp. z o.o.
Gdynia,
PolandActive - Recruiting
Pratia MCM Krakow
Krakow, 30-510
PolandActive - Recruiting
Biokinetica S.A., Przychodnia Jozefow
Warszawa,
PolandActive - Recruiting
Community Clinical Research Center
Anderson, Indiana 46013
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesSite Not Available
Anne Arundel Medical Center (AAMC)
Annapolis, Maryland 21401
United StatesSite Not Available
UT Health East Texas - Hope Cancer Center Tyler
Tyler, Minnesota 75702
United StatesActive - Recruiting
Westchester Medical Center
Hawthorne, New York 10532
United StatesActive - Recruiting
Texas Oncology, P.A. Amarillo, TX
Amarillo, Texas 79103
United StatesActive - Recruiting
Texas Oncology, P.A. Austin, TX
Austin, Texas 72007
United StatesActive - Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
Roanoke, Virginia 36274
United StatesActive - Recruiting
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