SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
- Registration Number
- NCT05642780
- Lead Sponsor
- Klus Pharma Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
- Subjects with expected survival β₯ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cohort C SKB264 subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort D SKB264 subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort B SKB264 subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Cohort E SKB264 subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort B Pembrolizumab subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort C Pembrolizumab subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort D Pembrolizumab subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Cohort E Pembrolizumab subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort A SKB264 subjects will receive SKB264 in combination with pembrolizumab by intravenous administration cohort A Pembrolizumab subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
- Primary Outcome Measures
Name Time Method 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 β₯ 50% measured twice β₯ 3 weeks apart
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Community Clinical Research Center
πΊπΈAnderson, Indiana, United States
Westchester Medical Center
πΊπΈHawthorne, New York, United States
Texas Oncology, P.A. Austin, TX
πΊπΈAustin, Texas, United States
Flinders Medical Centre
π¦πΊBedford Park, Australia
Wollongong Hospital
π¦πΊKogarah, Australia
Sun Yat-Sen University Cancer Center
π¨π³Guangzhou, China
Hubei Cancer Hospital
π¨π³Wuhan, Hubei, China
Affiliated Cancer Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Hunan Cancer Hospital
π¨π³Changsha, China
Jilin Cancer Hospital
π¨π³Changchun, Jinlin, China
The Second Hospital of Dalian
π¨π³Dalian, Liaoning, China
Weifang People's Hospital
π¨π³Weifang, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
π¨π³Xi'an, Shanxi, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
π¨π³Beijing, China
The First Affiliated Hospital of Jilin University
π¨π³Changchun, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, China
Chongqing Cancer Hospital
π¨π³Chongqing, China
Sun Yat-sen Memorial Hospital
π¨π³Guangzhou, China
Zhejiang Provincial People's Hospital
π¨π³Hangzhou, China
Qilu Hosptial of Qlilu University
π¨π³Jinan, China
Shandong Cancer Hospital
π¨π³Jinan, China
Fudan University Shanghai Cancer Center
π¨π³Shanghai, China
Obstetrics and Gynecology Hospital Affiliated to Fudan University
π¨π³Shanghai, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
π¨π³Wuhan, China
The First Affiliated Hospital of Wenzhou Medical University
π¨π³Wenzhou, China
Liaoning Cancer Hospital & Institute
π¨π³Shenyang, China
Zhongnan Hospital of Wuhan University
π¨π³Wuhan, China
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
π¨π³Zhengzhou, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Szpitale Pomorskie Sp. z o.o.
π΅π±Gdynia, Poland
The first Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, China
Pratia MCM Krakow
π΅π±Krakow, Poland
Biokinetica S.A., Przychodnia Jozefow
π΅π±Warszawa, Poland
Norton Cancer Institute
πΊπΈLouisville, Kentucky, United States
Texas Oncology, P.A. Amarillo, TX
πΊπΈAmarillo, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
πΊπΈRoanoke, Virginia, United States
UT Health East Texas - Hope Cancer Center Tyler
πΊπΈTyler, Minnesota, United States
Anne Arundel Medical Center (AAMC)
πΊπΈAnnapolis, Maryland, United States
Grand HΓ΄pital de Charleroi - Site Notre-Dame
π§πͺCharleroi, Belgium
Cliniques Universitaires Saint-Luc
π§πͺWoluwe-Saint-Lambert, Belgium
Icon Cancer Centre Wesley
π¦πΊAuchenflower, Queensland, Australia
BC Cancer - Kelowna
π¨π¦Kelowna, British Columbia, Canada
Algemeen Ziekenhuis Klina
π§πͺBrasschaat, Belgium
Centre Hospitalier de l'UniversitΓ© de MontrΓ©al (CHUM)
π¨π¦Montreal, Canada
Nanjing Drum Tower Hospital
π¨π³Nanjing, China
Peking University First Hospital
π¨π³Beijing, China