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New drug duo takes on multiple cancers in Mid-Stage trial

NCT ID NCT05642780

Disease control Sponsor: Klus Pharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study is testing a combination of two drugs, SKB264 and pembrolizumab (Keytruda), in 240 people with certain advanced solid tumors, including cervical, urothelial, ovarian, prostate, and endometrial cancers. The goal is to see if the combination is safe and effective at shrinking tumors. Participants receive both drugs by IV infusion over 42-day cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SKB264 (a drug given by IV) plus pembrolizumab (Keytruda, an immunotherapy drug)
What this could lead to
If it works, this combination could offer a new treatment option for several hard-to-treat cancers.
What could go wrong
This is an early-phase (Phase 2) study with only 240 people, so results may not apply to everyone. Side effects from the drug combination are possible and not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma endometrial carcinoma metastatic prostate carcinoma ovarian cancer prostate cancer urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

Contacts and locations

Locations

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • Algemeen Ziekenhuis Klina

    Brasschaat, Belgium

  • Anne Arundel Medical Center (AAMC)

    Annapolis, Maryland, 21401, United States

  • BC Cancer - Kelowna

    Kelowna, British Columbia, V1Y5L3, Canada

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, China

  • Biokinetica S.A., Przychodnia Jozefow

    Warsaw, Poland

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

    Montreal, Canada

  • Chongqing Cancer Hospital

    Chongqing, China

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Belgium

  • Community Clinical Research Center

    Anderson, Indiana, 46013, United States

  • Flinders Medical Centre

    Bedford Park, Australia

  • Fudan University Shanghai Cancer Center

    Shanghai, China

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi, Belgium

  • Henan Cancer Hospital

    Zhengzhou, China

  • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit

    Zhengzhou, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Hunan Cancer Hospital

    Changsha, China

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066, Australia

  • Jilin Cancer Hospital

    Changchun, Jinlin, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Obstetrics and Gynecology Hospital Affiliated to Fudan University

    Shanghai, China

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

    Roanoke, Virginia, 36274, United States

  • Peking University First Hospital

    Beijing, China

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Qilu Hosptial of Qlilu University

    Jinan, China

  • Shandong Cancer Hospital

    Jinan, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, China

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, Poland

  • Texas Oncology, P.A. Amarillo, TX

    Amarillo, Texas, 79103, United States

  • Texas Oncology, P.A. Austin, TX

    Austin, Texas, 72007, United States

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

  • The First Affiliated Hospital of Jilin University

    Changchun, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, China

  • The Second Hospital of Dalian

    Dalian, Liaoning, China

  • The first Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • UT Health East Texas - Hope Cancer Center Tyler

    Tyler, Minnesota, 75702, United States

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

    Wuhan, China

  • Weifang People's Hospital

    Weifang, Shandong, China

  • Westchester Medical Center

    Hawthorne, New York, 10532, United States

  • Wollongong Hospital

    Kogarah, Australia

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, China

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