SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Last updated: October 9, 2025
Sponsor: Klus Pharma Inc.
Overall Status: Active - Not 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

    Site Not Available

  • Icon Cancer Centre Wesley

    Auchenflower 6943571, Queensland 2152274 4066
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park,
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918,
    Australia

    Site Not Available

  • Wollongong Hospital

    Kogarah,
    Australia

    Site Not Available

  • Wollongong Hospital

    Kogarah 2161185,
    Australia

    Site Not Available

  • Algemeen Ziekenhuis Klina

    Brasschaat,
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Klina

    Brasschaat 2801117,
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi,
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi 2800481,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert 2783476,
    Belgium

    Site Not Available

  • BC Cancer - Kelowna

    Kelowna, British Columbia V1Y5L3
    Canada

    Site Not Available

  • BC Cancer - Kelowna

    Kelowna 5990579, British Columbia 5909050 V1Y5L3
    Canada

    Site Not Available

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

    Montreal,
    Canada

    Site Not Available

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

    Montreal 6077243,
    Canada

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Site Not Available

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning 1799869, Guangxi 1809867
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan 1791247, Hubei 1806949
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jinlin
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun 2038180, Jinlin
    China

    Site Not Available

  • The Second Hospital of Dalian

    Dalian, Liaoning
    China

    Site Not Available

  • The Second Hospital of Dalian

    Dalian 1814087, Liaoning 2036115
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang, Shandong
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang 1791681, Shandong 1796328
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an 11474004, Shanxi 1795912
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670,
    China

    Site Not Available

  • The First Affiliated Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jilin University

    Changchun 2038180,
    China

    Site Not Available

  • Chongqing Cancer Hospital

    Chongqing,
    China

    Site Not Available

  • Chongqing Cancer Hospital

    Chongqing 1814906,
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou 1809858,
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou 1808926,
    China

    Site Not Available

  • Qilu Hosptial of Qlilu University

    Jinan,
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan,
    China

    Active - Recruiting

  • Qilu Hosptial of Qlilu University

    Jinan 1805753,
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753,
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing,
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962,
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

  • Obstetrics and Gynecology Hospital Affiliated to Fudan University

    Shanghai,
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236,
    China

    Site Not Available

  • Obstetrics and Gynecology Hospital Affiliated to Fudan University

    Shanghai 1796236,
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang,
    China

    Site Not Available

  • Liaoning Cancer Hospital & Institute

    Shenyang 2034937,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388,
    China

    Site Not Available

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

    Wuhan,
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

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

    Wuhan 1791247,
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247,
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou,
    China

    Site Not Available

  • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit

    Zhengzhou,
    China

    Active - Recruiting

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658,
    China

    Site Not Available

  • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit

    Zhengzhou 1784658,
    China

    Site Not Available

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658,
    China

    Site Not Available

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia,
    Poland

    Site Not Available

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia 3099424,
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, 30-510
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow 3094802, 30-510
    Poland

    Site Not Available

  • Biokinetica S.A., Przychodnia Jozefow

    Warsaw 756135,
    Poland

    Site Not Available

  • Biokinetica S.A., Przychodnia Jozefow

    Warszawa,
    Poland

    Site Not Available

  • Community Clinical Research Center

    Anderson, Indiana 46013
    United States

    Site Not Available

  • Community Clinical Research Center

    Anderson 4917592, Indiana 4921868 46013
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Anne Arundel Medical Center (AAMC)

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Anne Arundel Medical Center (AAMC)

    Annapolis 4347242, Maryland 4361885 21401
    United States

    Site Not Available

  • UT Health East Texas - Hope Cancer Center Tyler

    Tyler, Minnesota 75702
    United States

    Site Not Available

  • UT Health East Texas - Hope Cancer Center Tyler

    Tyler 5050847, Minnesota 5037779 75702
    United States

    Site Not Available

  • Westchester Medical Center

    Hawthorne, New York 10532
    United States

    Site Not Available

  • Westchester Medical Center

    Hawthorne 5120284, New York 5128638 10532
    United States

    Site Not Available

  • Texas Oncology, P.A. Amarillo, TX

    Amarillo, Texas 79103
    United States

    Site Not Available

  • Texas Oncology, P.A. Austin, TX

    Austin, Texas 72007
    United States

    Site Not Available

  • Texas Oncology, P.A. Amarillo, TX

    Amarillo 5516233, Texas 4736286 79103
    United States

    Site Not Available

  • Texas Oncology, P.A. Austin, TX

    Austin 4671654, Texas 4736286 72007
    United States

    Site Not Available

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

    Roanoke, Virginia 36274
    United States

    Site Not Available

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

    Roanoke 4782167, Virginia 6254928 36274
    United States

    Site Not Available

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