SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Last updated: December 16, 2024
Sponsor: Klus Pharma Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Neuroblastoma

Treatment

Pembrolizumab

SKB264

Clinical Study ID

NCT05642780
SKB264-II-06
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 inSolid 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 theexception of toxicities not considered a safety risk.

  11. Contraceptive use by men and women must be consistent with local regulationsregarding 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

Exclusion Criteria:

  1. Subjects with active or untreated central nervous system (CNS) metastases and/orcarcinomatous 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 wellcontrolled.

  6. Subjects with known active tuberculosis.

  7. Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients ofpembrolizumab 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 evaluationof the study intervention or the safety of the subjects or the interpretation of theresults of the study.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 2
Study Start date:
January 17, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park,
    Australia

    Active - Recruiting

  • Wollongong Hospital

    Kogarah,
    Australia

    Active - Recruiting

  • Algemeen Ziekenhuis Klina

    Brasschaat,
    Belgium

    Active - Recruiting

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi,
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert,
    Belgium

    Active - Recruiting

  • BC Cancer - Kelowna

    Kelowna, British Columbia V1Y5L3
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal,
    Canada

    Active - Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jinlin
    China

    Active - Recruiting

  • The Second Hospital of Dalian

    Dalian, Liaoning
    China

    Active - Recruiting

  • Weifang People's Hospital

    Weifang, Shandong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Active - Recruiting

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha,
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing,
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Qilu Hosptial of Qlilu University

    Jinan,
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan,
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing,
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

  • Obstetrics and Gynecology Hospital Affiliated to Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit

    Zhengzhou,
    China

    Active - Recruiting

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia,
    Poland

    Active - Recruiting

  • Pratia MCM Krakow

    Krakow, 30-510
    Poland

    Active - Recruiting

  • Biokinetica S.A., Przychodnia Jozefow

    Warszawa,
    Poland

    Active - Recruiting

  • Community Clinical Research Center

    Anderson, Indiana 46013
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Anne Arundel Medical Center (AAMC)

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • UT Health East Texas - Hope Cancer Center Tyler

    Tyler, Minnesota 75702
    United States

    Active - Recruiting

  • Westchester Medical Center

    Hawthorne, New York 10532
    United States

    Active - Recruiting

  • Texas Oncology, P.A. Amarillo, TX

    Amarillo, Texas 79103
    United States

    Active - Recruiting

  • Texas Oncology, P.A. Austin, TX

    Austin, Texas 72007
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA

    Roanoke, Virginia 36274
    United States

    Active - Recruiting

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