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Clinical Trials in the USA / NCT05642780
Active, not recruiting Phase 2

SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

NCT05642780 · tracked via the Priya Life Science USA tracker
Sponsor
Klus Pharma Inc.
Phase
Phase 2
Started
2023-01-17
Last updated
2025-10-14

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

SKB264 →Pembrolizumab →

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)

Trial sites (48)

FacilityCityRegionStatus
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.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Klus Pharma Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT05642780 on ClinicalTrials.gov ↗ ← All trials in the USA