SKB264: be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Pembrolizumab: be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Study summary
The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
2. Subjects with expected survival ≥ 3 months.
3. Cohort A: Subjects with recurrent or metastatic cervical cancer
4. Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
5. Cohort C: Subjects with recurrent ovarian cancer
6. Cohort D: Subjects with metastatic prostate cancer
7. Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
8. Subjects able to provide tumor blocks or slides for biomarker test.
9. Subjects have relatively good organ function and bone marrow function.
10. Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
11. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
12. Subject is capable of giving signed informed consent.
13. Cohort E: Subjects with advanced endometrial cancer.
Exclusion Criteria:
1. Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Subjects who suffer from cardiovascular diseases of clinical significance.
3. Subjects with serious and/or uncontrolled concomitant diseases.
4. Subjects diagnosed active hepatitis B or hepatitis C.
5. Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
6. Subjects with known active tuberculosis.
7. Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
8. Subjects with history of allogeneic tissue/solid organ transplant.
9. Subjects previously treated with TROP2 targeted therapy.
10. 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.
11. Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
12. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
Primary outcome measure(s)
Dose limiting toxicity (DLT) and adverse events (AEs) — From subject sign the ICF to 30 days after the last dose of study treatment Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Objective Response Rate (ORR) — From baseline until disease progression, death or other protocol defined reason up to approximately 21 months ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.
Prostate-specific antigen (PSA) response rate (Cohort D) — From baseline until disease progression, death or other protocol defined reason up to approximately 21 months The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart
Trial sites (48)
Facility
City
Region
Status
Community Clinical Research Center
Anderson
Indiana
Norton Cancer Institute
Louisville
Kentucky
Anne Arundel Medical Center (AAMC)
Annapolis
Maryland
UT Health East Texas - Hope Cancer Center Tyler
Tyler
Minnesota
Westchester Medical Center
Hawthorne
New York
Texas Oncology, P.A. Amarillo, TX
Amarillo
Texas
Texas Oncology, P.A. Austin, TX
Austin
Texas
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
Roanoke
Virginia
Icon Cancer Centre Wesley
Auchenflower
Queensland
Flinders Medical Centre
Bedford Park
Australia
Wollongong Hospital
Kogarah
Australia
Algemeen Ziekenhuis Klina
Brasschaat
Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi
Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
Belgium
BC Cancer - Kelowna
Kelowna
British Columbia
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal
Canada
Sun Yat-Sen University Cancer Center
Guangzhou
Guangdong
Affiliated Cancer Hospital of Guangxi Medical University
Nanning
Guangxi
Hubei Cancer Hospital
Wuhan
Hubei
Hunan Cancer Hospital
Changsha
Hunan
Jilin Cancer Hospital
Changchun
Jinlin
The Second Hospital of Dalian
Dalian
Liaoning
Weifang People's Hospital
Weifang
Shandong
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing
China
Peking University First Hospital
Beijing
China
The First Affiliated Hospital of Jilin University
Changchun
China
Hunan Cancer Hospital
Changsha
China
Chongqing Cancer Hospital
Chongqing
China
Sun Yat-sen Memorial Hospital
Guangzhou
China
Sun Yat-Sen University Cancer Center
Guangzhou
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
China
Zhejiang Provincial People's Hospital
Hangzhou
China
Qilu Hosptial of Qlilu University
Jinan
China
Shandong Cancer Hospital
Jinan
China
Nanjing Drum Tower Hospital
Nanjing
China
Fudan University Shanghai Cancer Center
Shanghai
China
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Shanghai
China
Liaoning Cancer Hospital & Institute
Shenyang
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
China
+ 8 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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