SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

October 9, 2025 updated by: Klus Pharma Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia
        • Flinders Medical Centre
      • Kogarah, Australia
        • Wollongong Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Centre Wesley
  • Belgium
      • Brasschaat, Belgium
        • Algemeen Ziekenhuis klina
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi - Site Notre-Dame
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques Universitaires Saint-luc
  • Canada
      • Montreal, Canada
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • BC Cancer - Kelowna
  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
      • Changchun, China
        • The first Affiliated Hospital of Jilin University
      • Changsha, China
        • Hunan Cancer Hospital
      • Chongqing, China
        • Chongqing Cancer Hospital
      • Guangzhou, China
        • Sun Yat-sen University Cancer Center
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China
        • Sun Yat-Sen Memorial Hospital
      • Hangzhou, China
        • Zhejiang Provincial People's Hospital
      • Jinan, China
        • Shandong Cancer Hospital
      • Jinan, China
        • Qilu Hosptial of Qlilu University
      • Nanjing, China
        • Nanjing Drum Tower Hospital
      • Shanghai, China
        • Fudan University Shanghai Cancer Center
      • Shanghai, China
        • Obstetrics and Gynecology Hospital Affiliated to Fudan University
      • Shenyang, China
        • Liaoning Cancer Hospital & Institute
      • Wenzhou, China
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China
        • Zhongnan Hospital of Wuhan University
      • Wuhan, China
        • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
      • Zhengzhou, China
        • Henan Cancer Hospital
      • Zhengzhou, China
        • The first affiliated hospital of Zhengzhou university
      • Zhengzhou, China
        • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen University Cancer Center
    • Guangxi
      • Nanning, Guangxi, China
        • Affiliated Cancer Hospital of Guangxi Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
    • Jinlin
      • Changchun, Jinlin, China
        • Jilin Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, China
        • The second Hospital of dalian
    • Shandong
      • Weifang, Shandong, China
        • Weifang People's Hospital
    • Shanxi
      • Xi’an, Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
  • Poland
      • Gdynia, Poland
        • Szpitale Pomorskie Sp. z o.o.
      • Krakow, Poland, 30-510
        • Pratia MCM Krakow
      • Warsaw, Poland
        • Biokinetica S.A., Przychodnia Jozefow
  • United States
    • Indiana
      • Anderson, Indiana, United States, 46013
        • Community Clinical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center (AAMC)
    • Minnesota
      • Tyler, Minnesota, United States, 75702
        • UT Health East Texas - Hope Cancer Center Tyler
    • New York
      • Hawthorne, New York, United States, 10532
        • Westchester Medical Center
    • Texas
      • Amarillo, Texas, United States, 79103
        • Texas Oncology, P.A. Amarillo, TX
      • Austin, Texas, United States, 72007
        • Texas Oncology, P.A. Austin, TX
    • Virginia
      • Roanoke, Virginia, United States, 36274
        • Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort A
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Drug: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Drug: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Other Names:
  • Keytruda
Experimental: cohort B
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Drug: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Drug: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Other Names:
  • Keytruda
Experimental: cohort C
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Drug: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Drug: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Other Names:
  • Keytruda
Experimental: cohort D
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Drug: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Drug: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Other Names:
  • Keytruda
Experimental: Cohort E
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Drug: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Drug: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity (DLT) and adverse events (AEs)
Time Frame: 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.
From subject sign the ICF to 30 days after the last dose of study treatment
Objective Response Rate (ORR)
Time Frame: 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.
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Prostate-specific antigen (PSA) response rate (Cohort D)
Time Frame: 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 ≥ 50% measured twice ≥ 3 weeks apart
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klus Pharma Inc.

Collaborators

Myriad Genetics, Inc.
Frontage Laboratories, Inc.
Clario
Discovery Life Sciences, LLC
Ventana Medical Systems, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 9, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKB264-II-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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