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Study on the Safety and Effectiveness of SKB264 and Pembrolizumab for Patients with Cervical, Urothelial, Ovarian, or Prostate Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for certain types of cancer, specifically cervical cancer, urothelial carcinoma, ovarian cancer, and prostate cancer. The treatment being tested combines two medications: SKB264 and pembrolizumab. SKB264 is an experimental drug, while pembrolizumab is a medication already used in cancer treatment. The purpose of this study is to determine if this combination can effectively treat these cancers.

Participants in the study will receive the treatment over a period of up to 24 months. The treatment involves administering the medications through an intravenous infusion, which means they are given directly into the bloodstream through a vein. Throughout the study, participants will be monitored for any side effects and to see how well the treatment is working. This includes regular check-ups, blood tests, and other assessments to ensure the safety and effectiveness of the treatment.

The study will also involve a comparison with a placebo to better understand the effects of the treatment. The main focus will be on the safety of the treatment, looking at any side effects that occur, and its effectiveness, such as whether the cancer shrinks or stops growing. The study aims to provide valuable information that could lead to new treatment options for these types of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted. This includes a review of medical history and a physical examination to confirm eligibility.

    Tests such as blood work, imaging scans, and other necessary evaluations will be performed to establish a baseline for your health status.

  2. Step 2

    Treatment administration

    The treatment involves the administration of two medications: SKB264 and pembrolizumab. Both are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    SKB264 and pembrolizumab will be administered according to the study schedule, which will be explained in detail by the medical team. The frequency and dosage will be determined based on the study protocol.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the safety and effectiveness of the treatment. This includes checking vital signs, conducting physical examinations, and performing laboratory tests.

    Additional tests such as electrocardiograms (to check heart function) and imaging scans may be done to monitor the response to treatment.

  4. Step 4

    Evaluation of treatment response

    The response to the treatment will be evaluated by measuring changes in tumor size and other relevant health indicators.

    The study will also assess the duration of response, progression-free survival (time during which the disease does not worsen), and overall survival.

  5. Step 5

    Completion of study participation

    Upon completion of the study, a final assessment will be conducted to evaluate overall health and any changes since the start of the trial.

    Participants will receive information about their health status and any necessary follow-up care.

Who can join the trial?

4 criteria

  • Participants must be 18 years or older.
  • Both men and women can join the study.
  • Participants must have a diagnosis of one of the following cancers: Cervical cancer, Urothelial carcinoma (a type of bladder cancer), Ovarian cancer, or Prostate cancer.
  • The cancer must be locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body), or it must have come back after treatment.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer not listed in the study.
  • Patients who have had a severe allergic reaction to similar medications in the past.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments recently that might affect the study results.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

  • SKB264

    is a new experimental drug being tested to see if it can help treat certain types of solid tumors. In this study, researchers are looking at how well SKB264 works when used together with another medication. The goal is to find out if this combination can help shrink tumors or stop them from growing, and to see if it is safe for patients to use.

  • Pembrolizumab

    is a medication that helps the body's immune system fight cancer. It works by blocking a specific protein that cancer cells use to hide from the immune system. By blocking this protein, pembrolizumab helps the immune system recognize and attack cancer cells. In this study, it is being used in combination with SKB264 to see if the two drugs together can be more effective in treating certain solid tumors.

What is already known about the treatment

  • SKB264

    SKB264 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials to determine its safety and effectiveness in treating certain types of cancer, including cervical, urothelial, ovarian, and prostate cancers. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells more effectively. SKB264 is classified as an investigational drug, which means it is still being researched and is not yet approved for general medical use.

  • Pembrolizumab

    Pembrolizumab is also administered as an intravenous infusion. It is a well-established medication in the field of oncology, widely used and documented in medical literature for its role in treating various cancers. Pembrolizumab is primarily used to treat cancers such as melanoma, lung cancer, and others by blocking a protein called PD-1, which helps the immune system to better detect and fight cancer cells. It belongs to a class of drugs known as immune checkpoint inhibitors, which enhance the body's immune response against cancer.

Investigated diseases

  • Cervical cancer

    Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It typically begins with precancerous changes in the cervical cells, often caused by persistent infection with certain types of human papillomavirus (HPV). As the disease progresses, these abnormal cells can develop into cancerous cells and invade deeper tissues of the cervix and surrounding areas. In advanced stages, the cancer may spread to other parts of the body, including the bladder, rectum, and distant organs. The progression from precancerous changes to invasive cancer can take several years, allowing for potential early detection through screening.

  • Urothelial carcinoma

    Urothelial carcinoma, also known as transitional cell carcinoma, is the most common type of bladder cancer. It originates in the urothelial cells that line the inside of the bladder and can also occur in other parts of the urinary tract, such as the ureters and renal pelvis. The disease often begins as superficial tumors that affect only the inner lining of the bladder. Over time, these tumors can grow deeper into the bladder wall and potentially spread to nearby lymph nodes and other organs. The progression of the disease can vary, with some tumors remaining non-invasive while others become more aggressive.

  • Ovarian cancer

    Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands responsible for producing eggs. It often starts in the outer layer of the ovaries and can spread to other parts of the pelvis and abdomen. The disease is known for its subtle symptoms in the early stages, which can lead to delayed diagnosis. As ovarian cancer progresses, it can invade nearby tissues and organs, and eventually spread to distant parts of the body. The progression can be rapid or slow, depending on the type and grade of the cancer cells.

  • Prostate cancer

    Prostate cancer is a common cancer that occurs in the prostate gland, which is a small gland in men that produces seminal fluid. It often begins as small clusters of cancerous cells within the prostate and can grow slowly over many years. In some cases, the cancer may remain confined to the prostate, while in others, it can grow more aggressively and spread to nearby tissues and bones. The progression of prostate cancer can vary widely, with some forms being slow-growing and others more aggressive. Early stages may not cause noticeable symptoms, but as the disease advances, it can lead to urinary and other systemic symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502654-14-00Protocol codeSKB264-II-06Estimated enrolment318 patientsSponsorSichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

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