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Study of BMS-986504 alone or in drug combination in adults with advanced or metastatic solid tumors with MTAP deletion

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

The trial focuses on patients with advanced and/or metastatic solid tumors with homozygous MTAP deletion. A solid tumor is a lump of abnormal cells that forms in organs such as the lung, breast, or colon. When the disease is metastatic, the cancer cells have spread from the original site to other parts of the body. Homozygous means that both copies of a specific gene are missing, and the missing gene, called MTAP deletion, can influence how the cancer grows. The investigational medicine being tested is BMS-986504, which may be given alone or together with other standard cancer medicines.

The main aim of the study is to evaluate how often the tumors shrink, known as an objective response. Participants receive the study drug in treatment cycles that repeat every few weeks, with regular visits for physical exams, blood tests, and imaging scans to check the size of the tumor and overall health.

Tumor shrinkage is classified as a complete response when the cancer disappears, a partial response when the tumor size decreases by a significant amount, or stable disease when the tumor does not grow or shrink much. Throughout the trial, doctors monitor for adverse events, which are side effects or any unwanted medical problems, and record any that are serious or lead to stopping the treatment.

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

    First dose and start of treatment

    After joining the study you receive the first dose of the study drug bms‑986504. the exact amount and schedule are defined by the study protocol.

    At the same visit you may also receive other cancer medicines that are part of the combination treatment. each medicine is given at a dose of 9999 mg.

    The medicines are given by different routes:

    temozolomide – taken orally (by mouth)

    gemcitabine – given intravenously (through a vein) as a solution

    paclitaxel – given intravenously

    pacitaxel albumin‑bound – given intravenously

    carboplatin – given intravenously

    navlimetostat – taken orally as a film‑coated tablet

    pemetrexed – given intravenously

    cisplatin – given intravenously

    bnt327 20 mg ml and bnt327 50 mg ml – given intravenously as a concentrate for infusion

  2. Step 2

    Repeated treatment cycles

    Treatment is continued in cycles. each cycle repeats the same set of medicines at the same dose of 9999 mg.

    The interval between cycles is defined by the study protocol and may be several weeks, allowing time for recovery between doses.

  3. Step 3

    Regular safety and response monitoring

    Throughout the treatment you attend scheduled visits where health professionals check for side effects, laboratory changes, and any signs that the tumor is responding.

    Adverse events (any unwanted effects) and serious adverse events (effects that are severe or require hospitalization) are recorded at each visit.

  4. Step 4

    End of treatment assessment

    When the predefined number of cycles is completed or if the study drug is stopped early because of side effects or disease progression, a final assessment is performed.

    The assessment looks at tumor response (shrinkage or stability) and overall safety.

  5. Step 5

    Follow‑up period

    After treatment ends you continue to be followed for a period of time to monitor long‑term safety and any further changes in tumor size.

    Follow‑up visits occur at intervals set by the study protocol.

Who can join the trial?

10 criteria

  • Have a tissue diagnosis confirming an advanced or metastatic solid tumor that shows a homozygous deletion (both copies missing) of the MTAP gene.
  • Be 18 years or older at the time of signing the consent form.
  • Have a confirmed Stage III (cannot be removed by surgery) or Stage IV (has spread) melanoma according to the AJCC 8th edition staging system.
  • Have a confirmed advanced gastric adenocarcinoma (stomach cancer, including the gastroesophageal junction) or squamous esophageal cancer (cancer of the esophagus lining).
  • Have a confirmed surgically unresectable locally advanced or metastatic urothelial carcinoma (bladder cancer), which may include other tissue types.
  • Have a confirmed supratentorial glioblastoma (an aggressive brain tumor located in the upper part of the brain).
  • Have a newly diagnosed confirmed supratentorial glioblastoma, Grade IV malignant glioma (including gliosarcoma) as defined by the World Health Organization.
  • Have a confirmed metastatic (Stage IV or recurrent) non‑small cell lung cancer (NSCLC).
  • Have a confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
  • Both male and female patients are eligible.

Who cannot join the trial?

4 criteria

  • You cannot join if you have spinal cord compression – this means pressure on the nerves that run down your back, which can cause pain, weakness, or loss of feeling.
  • You cannot join if you have active cancer spots in the brain (brain metastases) or cancer spread to the thin membranes covering the brain and spinal cord (leptomeningeal metastases).
  • You cannot join if you have ever had a fistula (an abnormal tunnel connecting two organs), a perforation (a hole) in your digestive system, or an intra‑abdominal abscess (a pocket of infection inside the belly).
  • You cannot join if you have heart problems (cardiac abnormalities) such as a low left ventricular ejection fraction, which means the heart is not pumping blood efficiently.
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Investigated drugs

  • Temozolomide

    is an oral chemotherapy medicine taken by mouth. It works by interfering with the DNA of cancer cells, which can help stop the tumor from growing or spreading. In this study it is given as part of the treatment plan to see how well it works alone or together with other drugs.

  • Gemcitabine

    is a chemotherapy drug given through a vein (intravenous). It blocks the ability of cancer cells to make new DNA, which can cause the cells to die. The trial uses gemcitabine to test its effect on shrinking tumors when used by itself or in combination with other agents.

  • Paclitaxel

    is an IV chemotherapy medication that stops cancer cells from dividing by stabilizing their internal structure. It is administered through a vein and is being studied to see how it contributes to tumor reduction, either alone or with other treatments.

  • Paclitaxel Albumin‑Bound

    (often called nab‑paclitaxel) is a form of paclitaxel that is attached to albumin particles, allowing it to be given intravenously without some of the solvents used in regular paclitaxel. This can sometimes reduce side effects. In the trial it is tested for its ability to help shrink tumors.

  • Carboplatin

    is an IV chemotherapy drug that damages the DNA of cancer cells, leading to cell death. It is included in the study to evaluate its effectiveness in controlling tumor growth when used alone or with other drugs.

  • Navlimetostat

    is an oral, film‑coated tablet that belongs to a newer class of medicines targeting specific pathways in cancer cells. Patients take it by mouth, and the trial is looking at how well it can stop tumor growth, either by itself or together with other agents.

What is already known about the treatment

  • Temozolomide

    This medicine is taken by mouth as a tablet. It is an approved drug used mainly for brain tumors such as glioblastoma and for some skin cancers. It works by adding a small chemical group to the DNA of cancer cells, which damages the DNA and stops the cells from growing. It belongs to the class of alkylating chemotherapy agents.

  • Gemcitabine

    This drug is given by intravenous infusion into a vein. It is approved for cancers of the pancreas, lung, and breast. It mimics a building block of DNA, so when cancer cells try to copy their DNA they make mistakes and stop growing. It is classified as a nucleoside analog antimetabolite.

  • Paclitaxel

    This medication is administered by intravenous infusion. It is approved for several solid tumors, including breast, ovarian and lung cancers. It works by locking the tiny tubes (microtubules) that cells need to divide, so the cancer cells cannot multiply. It is a taxane‑type chemotherapy drug.

  • Paclitaxel Albumin‑Bound

    This form of paclitaxel is also given by intravenous infusion, but it is bound to albumin particles that help it dissolve better. It is used for the same cancers as regular paclitaxel, such as breast and lung cancer. It stabilizes microtubules in the same way, preventing cancer cells from dividing. It is a nanoparticle albumin‑bound taxane.

  • Carboplatin

    This drug is given by intravenous infusion. It is an approved treatment for ovarian, lung and head‑and‑neck cancers. It works by forming links between DNA strands, which blocks the cancer cells from copying their DNA and leads to cell death. It belongs to the class of platinum‑based chemotherapy agents.

  • Navlimetostat

    This medicine is taken orally as a film‑coated tablet. It is still being studied and is not yet approved for general use. It is designed to block a specific enzyme that tumor cells with MTAP loss need to grow. It is classified as an experimental targeted oral therapy.

Investigated diseases

Metastatic solid tumor with homozygous MTAP deletion - These are cancers that have spread from their original organ to other parts of the body. The tumors lack both copies of the MTAP gene, which can affect how the cancer cells grow and divide. As the condition progresses, existing tumors may become larger and new tumor sites can appear in distant tissues. The disease typically follows a pattern of gradual expansion and increasing tumor burden.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524285-18-00Protocol codeCA240-0005Estimated enrolment260 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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