SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Running, not enrolling · Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05642780

Run by

Klus Pharma Inc.

People needed

240

Starts

2023-01-17

Expected to finish

2027-12-31

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 in Solid 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 the exception of toxicities not considered a safety risk.
• Contraceptive use by men and women must be consistent with local regulations regarding 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.

You may not qualify if…

• Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous 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 well controlled.
• Subjects with known active tuberculosis.
• Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab 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 evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.