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Effect of Food on Absorption of 2-(3-(3,5-dimethyltriazol-4-yl)-5-((s)-oxan-4-yl(phenyl)methyl)pyrido(3,2-b)indol-7-yl)propan-2-ol in Advanced Solid Tumors Participants

Fast replyInvestigationalNo placebo
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What is this trial about?

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

The trial involves participants who have Advanced Solid Tumors, which are cancers that have grown beyond their original location and cannot be removed by surgery. The investigational medicine being examined is an oral capsule that contains the drug BMS-986158, a type of BET‑inhibitor designed to interfere with proteins that help cancer cells grow.

The purpose of the study is to determine how food influences the bioavailability of the medication, meaning how much of the drug reaches the bloodstream when taken. Each participant will receive a single dose of the capsule on two separate occasions: once after eating a high‑fat, high‑calorie meal and once after an overnight fast, with the order decided randomly. Blood will be drawn after each dose to measure drug levels, and safety will be checked by monitoring any side effects or health problems that occur during the short observation period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You will attend an initial visit after joining the study. during this visit you will give informed consent, provide your medical history, and undergo baseline examinations such as blood tests and physical measurements.

  2. Step 2

    Randomization to study sequence

    After the initial assessments you will be randomly assigned to one of two sequences. the sequences determine whether you receive the medication while fasted first and fed later, or fed first and fasted later.

  3. Step 3

    First dosing period

    You will receive a single oral dose of bms-986158 in a 3 mg soft gelatin capsule.

    If your assigned condition is fasted, you will fast overnight (no food or drink except water) before taking the capsule with a glass of water and will remain without food for several hours after dosing.

    If your assigned condition is fed, you will eat a high‑fat, high‑calorie meal as instructed, then take the capsule with a glass of water shortly after the meal.

    Blood samples will be taken at multiple time points after the dose to measure how the drug is absorbed in your body.

  4. Step 4

    Washout period

    After the first dosing period you will have a washout interval during which no study medication is taken. this interval allows the drug to be cleared from your system before the next dosing period.

  5. Step 5

    Second dosing period

    You will receive a second single oral dose of bms-986158 3 mg capsule under the opposite condition from the first period (fed if the first was fasted, or fasted if the first was fed).

    The same procedures for taking the medication and for blood sampling will be followed as in the first dosing period.

  6. Step 6

    Safety monitoring throughout the study

    Throughout both dosing periods you will be asked to report any side effects or health changes.

    Regular safety checks, including vital signs and laboratory tests, will be performed to monitor your well‑being.

  7. Step 7

    Final study visit

    At the end of the study you will attend a final visit for concluding examinations, repeat laboratory tests, and a summary of the study procedures you completed.

Who can join the trial?

5 criteria

  • Be at least 18 years old when you sign the consent form.
  • Have a doctor‑confirmed (by testing your tissue or cells) advanced solid tumor that cannot be removed or has spread, and that can be seen on scans or measured; you must have already tried standard treatments that did not work, could not be used, or were not tolerated.
  • Show a clear sign of tumor growth on recent scans, described as radiographically documented progressive disease, after your most recent therapy.
  • Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to walk and take care of yourself but cannot do very strenuous activities (1).
  • Agree to eat a standard high‑fat, high‑calorie meal before taking the study drug (for example: two fried eggs, two strips of bacon, toast with butter, hash browns, and whole milk).

Who cannot join the trial?

3 criteria

  • Having a gastrointestinal disease (a problem with the stomach or intestines) now or in the past three months.
  • Having a second malignancy (another cancer) at the same time as the study cancer.
  • Having an uncontrolled or significant cardiovascular disease (serious heart or blood‑vessel problems).
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Investigated drugs

BMS-986158 is an experimental oral medication that belongs to a class called BET inhibitors. In this study, participants with advanced solid tumors took a single capsule of this drug. The researchers wanted to see how much of the medicine entered the bloodstream when it was taken on an empty stomach compared with after eating a high‑fat, high‑calorie meal. By comparing these two conditions, the trial helps determine whether food affects the drug’s absorption and overall effectiveness.

What is already known about the treatment

BMS-986158 - BMS-986158 is taken as an oral capsule; participants swallow the soft gelatin capsule with water, either after a high‑fat meal or on an empty stomach. The drug is an experimental BET inhibitor currently in early‑phase clinical studies and not yet approved for routine medical use. It is being investigated mainly for the treatment of advanced solid tumors, a type of cancer that has spread beyond its original site. The compound works by blocking bromodomain and extra‑terminal (BET) proteins, which helps to lower the activity of genes that promote tumor growth; it belongs to the class of epigenetic modulators known as BET inhibitors.

Investigated diseases

Advanced solid tumors - Advanced solid tumors are cancers that form a solid mass in organs or tissues such as the lung, breast, colon, or pancreas. They have grown beyond the original site and may involve nearby structures or spread to distant parts of the body. As the disease progresses, the tumor can enlarge, invade surrounding tissue, and form new lesions in other organs. This stage often reflects a more widespread involvement compared with early‑stage disease. The growth pattern can be irregular, and the cancer cells continue to divide and survive despite the body's defenses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506661-65-00Protocol codeCA011-1010Estimated enrolment60 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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