Clinical trial NCT05642780: SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Official title: A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Klus Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Myriad Genetics, Inc.
name: Discovery Life Sciences, LLC
name: Ventana Medical Systems, Inc
name: Frontage Laboratories, Inc.
First posted: 2022-12-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Dose limiting toxicity (DLT) and adverse events (AEs)
timeFrame: From subject sign the ICF to 30 days after the last dose of study treatment
measure: Objective Response Rate (ORR)
timeFrame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
measure: Prostate-specific antigen (PSA) response rate (Cohort D)
timeFrame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Annapolis
country: United States
facility: Anne Arundel Medical Center (AAMC)
state: Maryland
city: Tyler
country: United States
facility: UT Health East Texas - Hope Cancer Center Tyler
state: Minnesota
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: Amarillo
country: United States
facility: Texas Oncology, P.A. Amarillo, TX
state: Texas
city: Austin
country: United States
facility: Texas Oncology, P.A. Austin, TX
state: Texas
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
state: Virginia
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Kogarah
country: Australia
facility: Wollongong Hospital
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis Klina
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site Notre-Dame
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna
state: British Columbia
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jinlin
city: Dalian
country: China
facility: The Second Hospital of Dalian
state: Liaoning
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: The First Affiliated Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Jinan
country: China
facility: Qilu Hosptial of Qlilu University
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The first Affiliated Hospital of Zhengzhou University
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Warszawa
country: Poland
facility: Biokinetica S.A., Przychodnia Jozefow
Study officials:
References: