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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Vrije Universiteit Brussel Jette Belgium
Azienda Ospedaliera Di Perugia Perugia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Oslo University Hospital HF Oslo Norway
Centre Hospitalier Lyon Sud Pierre Benite France
Virgen del Rocío University Hospital Sevilla Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Czqshnywq Udewhjlrcydqgl Ssvflxusb Woluwe-Saint-Lambert Belgium
Hgrwd Bjryxq Hq Bergen Norway
Alqpeyw Okjmtfxcxpx Upsuxknhqqkrt Squvjj Siena Italy
Ugbcelsbvnwklctxsbrar Wznwvdjkz Apd Wuerzburg Germany
Ugxwokmnmw Mhvohaf Czpxhh Hmmmnyixmwkrjgggf Hamburg Germany
Azecdpm Oabvylvbztf Pqcw Guvirlbq Xqwrg Bergamo Italy
Ahkeqlerri Pkedgufj Hmsycvkc Dv Pqeaq Paris France
Cdif Uvzescbobl Hmrtrtna Cork Ireland
Hjbejkam Vzll ddvdwkwg Barcelona Spain
Ijdkicqc Cyqwud Davablqzbnzhlfzmr L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
28.05.2026
France France
Not yet recruiting
28.05.2026
Germany Germany
Not yet recruiting
28.05.2026
Ireland Ireland
Not yet recruiting
28.05.2026
Italy Italy
Not yet recruiting
28.05.2026
Norway Norway
Not yet recruiting
28.05.2026
Spain Spain
Not yet recruiting
28.05.2026

Trial locations

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.

Pemetrexed is an intravenous chemotherapy medication that blocks the production of nucleotides, the building blocks of DNA and RNA, which cancer cells need to multiply. The study uses pemetrexed to see how it affects tumor size when used alone or in combination.

Cisplatin is a well‑known IV chemotherapy drug that forms cross‑links in DNA, preventing cancer cells from dividing and causing them to die. It is being tested in the trial to determine its impact on tumor shrinkage, either as a single agent or with other treatments.

Pumitamig (BNT327) is an experimental drug given as a concentrate for infusion into a vein. It is being studied at different strengths (20 mg/ml and 50 mg/ml) to evaluate its potential to reduce tumor size, either by itself or when combined with other therapies.

BMS‑986504 is the investigational medicine that is the main focus of this study. It is given by mouth (or possibly by infusion, depending on the study design) and works by targeting a specific pathway that may be important in tumors with a missing MTAP gene. The trial is testing how well BMS‑986504 can shrink tumors when used alone or together with the other drugs listed above.

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 ID:
2025-524285-18-00
Protocol code:
CA240-0005
Trial Phase:
Therapeutic exploratory (Phase II)

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