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Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder 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 treatments for urothelial cancer, which is a type of cancer that affects the bladder and other parts of the urinary system. The study will explore the effectiveness of a new treatment called BT8009, both on its own and in combination with other medications. These medications include pembrolizumab, cisplatin, carboplatin, gemcitabine, and avelumab. The purpose of the study is to see how well these treatments work in slowing down the progression of the cancer or in reducing the size of the tumors.

Participants in the study will be divided into different groups. Some will receive BT8009 alone, while others will receive it in combination with pembrolizumab. Another group will receive a combination of chemotherapy drugs, which may include cisplatin or carboplatin with gemcitabine, and possibly avelumab as a maintenance treatment. The study will monitor the participants over a period of time to assess the effectiveness of these treatments in managing the cancer.

The trial aims to provide valuable information on how these treatments can help patients with advanced stages of urothelial cancer. By comparing the different treatment options, researchers hope to find the most effective approach to improve the outcomes for patients with this type of cancer. Participants will receive regular assessments to track the progress of their treatment and any changes in their condition.

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

    Joining the study

    Upon joining the study, participants are assigned to one of two groups, known as cohorts. Each cohort has a different treatment plan.

  2. Step 2

    Treatment for cohort 1

    Participants in Cohort 1 receive a combination of medications. This includes BT8009 and pembrolizumab, or chemotherapy with cisplatin or carboplatin and gemcitabine. If indicated, avelumab is used for maintenance.

    All medications are administered as a solution for infusion, which means they are given through a vein. The specific dosage and frequency depend on the treatment plan and medical guidance.

  3. Step 3

    Treatment for cohort 2

    Participants in Cohort 2 receive BT8009 as a single treatment or in combination with pembrolizumab. These medications are also administered as a solution for infusion.

    The dosage and frequency are determined by the treatment plan and medical guidance.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, participants undergo regular monitoring to assess the effectiveness of the treatment. This includes measuring progression-free survival and overall response rate using specific criteria.

    Evaluations are conducted by an independent review to ensure accuracy and objectivity.

  5. Step 5

    End of treatment

    The study continues until the estimated end date of December 31, 2030, or until specific endpoints are reached, such as disease progression or other criteria defined in the study.

    Participants are informed about the results and any further steps after the study concludes.

Who can join the trial?

14 criteria

  • Must be able to understand the study procedures and agree to participate by providing written consent.
  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of **locally advanced** (cannot be removed by surgery) or **metastatic** (cancer has spread to other parts of the body) **urothelial cancer** of the kidney area, ureter, bladder, or urethra. If the cancer has mixed types, the main type should be **transitional cell** (at least 50%).
  • Must have **measurable disease**, meaning the cancer can be measured using specific criteria. If the cancer was treated with radiation before, it should show signs of growth to be considered measurable.
  • Must have available tumor tissue from a previous or new sample for testing in a central lab.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ function, which includes:
    • **Total bilirubin** (a substance made by the liver) should be within normal limits, or slightly higher if the person has **Gilbert disease** (a mild liver disorder).
    • **Serum albumin** (a protein in the blood) should be at least 2.5 g/dL.
    • **Aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)** (liver enzymes) should be within normal limits, or slightly higher if there are liver metastases (cancer spread to the liver).
    • **Alkaline phosphatase** (an enzyme related to the liver and bones) should be within normal limits, or slightly higher if there are liver or bone metastases.
    • **Estimated glomerular filtration rate (eGFR)** (a measure of kidney function) should be at least 30 mL/min.
    • **International normalized ratio (INR)**/**prothrombin time (PT)** (measures of blood clotting) should be within normal limits unless taking blood thinners, in which case they should be within the therapeutic range.
    • Women who can have children must have a negative pregnancy test before starting the study.
    • Women and men must agree to use highly effective birth control methods during the study and for a specific time after the last dose of study drugs. Men must also agree not to donate sperm, and women must not breastfeed or donate eggs during this time.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than locally advanced or metastatic urothelial cancer cannot participate. This type of cancer affects the bladder and nearby areas.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have not recovered from previous treatments or surgeries may not be eligible to participate.
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Investigated drugs

  • BT8009

    is an investigational medication being studied for its potential to treat urothelial cancer. It is being tested both as a standalone treatment and in combination with another medication to see how well it works in stopping or slowing the growth of cancer.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is used in combination with BT8009 in this study to see if it can improve the effectiveness of the treatment for urothelial cancer.

  • Cisplatin

    is a chemotherapy drug used to treat various types of cancer, including urothelial cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing.

  • Carboplatin

    is another chemotherapy medication similar to cisplatin. It is used to treat cancer by interfering with the DNA of cancer cells, preventing them from multiplying.

  • Gemcitabine

    is a chemotherapy drug that is often used in combination with other medications to treat cancer. It works by blocking the ability of cancer cells to make DNA, which is necessary for them to grow and divide.

  • Avelumab

    is a medication that helps the immune system attack cancer cells. It is used as a maintenance therapy in this study, which means it is given after initial treatment to help keep the cancer from coming back or getting worse.

What is already known about the treatment

BT8009 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic urothelial cancer. It is being evaluated both as a monotherapy and in combination with pembrolizumab. The main therapeutic indication is to improve progression-free survival and overall response rate in cancer patients. BT8009 works by targeting specific proteins on cancer cells, disrupting their growth and survival. It is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

Investigated diseases

Locally advanced or metastatic urothelial cancer – This is a type of cancer that begins in the urothelial cells lining the bladder, ureters, or other parts of the urinary tract. When it is locally advanced, the cancer has spread beyond the original site but is still within the nearby tissues. In the metastatic stage, the cancer has spread to distant parts of the body, such as the lymph nodes, bones, or lungs. The disease progresses as cancer cells grow and invade surrounding tissues, potentially leading to symptoms like blood in the urine, pain, or difficulty urinating. As it advances, it may cause more systemic symptoms due to its spread to other organs. The progression can vary greatly among individuals, depending on factors like the cancer's location and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504231-41-01Protocol codeBT8009-230Estimated enrolment603 patientsSponsorBicycletx Limited

sourced from the EU Clinical Trials Register and site verification

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