SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
NCT ID: NCT05642780
Last Updated: 2025-10-14
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2023-01-17
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma
NCT05156268
Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
NCT04602377
A Study of Pembrolizumab With Standard Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer
NCT02608684
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer
NCT07261683
Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer
NCT05467670
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
cohort A
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
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;
cohort B
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
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;
cohort C
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
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;
cohort D
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
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;
Cohort E
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
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;
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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;
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Myriad Genetics, Inc.
INDUSTRY
Discovery Life Sciences, LLC
UNKNOWN
Ventana Medical Systems, Inc
UNKNOWN
Frontage Laboratories, Inc.
UNKNOWN
Clario
UNKNOWN
Klus Pharma Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Community Clinical Research Center
Anderson, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Anne Arundel Medical Center (AAMC)
Annapolis, Maryland, United States
UT Health East Texas - Hope Cancer Center Tyler
Tyler, Minnesota, United States
Westchester Medical Center
Hawthorne, New York, United States
Texas Oncology, P.A. Amarillo, TX
Amarillo, Texas, United States
Texas Oncology, P.A. Austin, TX
Austin, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
Roanoke, Virginia, United States
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
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, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, , Canada
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jinlin, China
The Second Hospital of Dalian
Dalian, Liaoning, China
Weifang People's Hospital
Weifang, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
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
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, , China
Zhongnan Hospital of Wuhan University
Wuhan, , China
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
Zhengzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Szpitale Pomorskie Sp. z o.o.
Gdynia, , Poland
Pratia MCM Krakow
Krakow, , Poland
Biokinetica S.A., Przychodnia Jozefow
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SKB264-II-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.