Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety and Effects of BMS-986507 with Pembrolizumab and Osimertinib Mesylate in Adults with Advanced Solid Tumors

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying advanced solid tumors, which are a group of cancers that form in solid organs or tissues. The study will explore the safety and effectiveness of a new treatment called BMS-986507, also known as BL-B01D1. This treatment will be tested in combination with other medications, including Pembrolizumab and Osimertinib Mesylate. The trial aims to find out if BMS-986507 is safe and to determine the highest dose that can be safely given to patients. The study will also evaluate the treatment in two specific types of lung cancer: EGFRmt non-small cell lung cancer (NSCLC) and EGFRwt NSCLC.

Participants in the study will receive the treatment through different methods, such as intravenous use, which involves administering the medication directly into a vein, or oral intake, which involves taking the medication by mouth. The study will monitor participants for any side effects and determine how the body processes the medication. The goal is to identify safe doses that can be tested in larger groups of patients in the future.

The trial will take place over several years, with an estimated end date in 2028. Throughout the study, researchers will collect data on the number of participants experiencing side effects, the concentration of the medication in the blood, and the overall response to the treatment. This information will help determine the potential benefits and risks of using BMS-986507 in treating advanced solid tumors and specific types of lung cancer.

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 to confirm eligibility. This includes verifying that there is at least one measurable lesion and assessing overall health status.

    A performance status evaluation will be conducted to ensure the ability to perform daily activities is either fully active or restricted in physically strenuous activity but ambulatory.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of pembrolizumab through an intravenous infusion. This involves receiving the medication directly into the bloodstream through a vein.

    Following this, osimertinib mesylate will be taken orally. The specific dosage and frequency will be determined by the study team based on individual needs and responses.

  3. Step 3

    Combination therapy

    In addition to the initial medications, BL-B01D1 will be administered intravenously. This is part of the combination therapy to evaluate its safety and effectiveness.

    The combination of these treatments aims to determine the maximum safe dose and to observe any potential side effects or adverse reactions.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring will occur to track the body's response to the treatment. This includes blood tests, imaging studies, and other necessary evaluations.

    The primary focus is to identify any adverse events, which are unexpected medical problems that occur during treatment, and to ensure the safety of the participant.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up visits will be scheduled to continue monitoring health status and any long-term effects of the treatment.

    These visits are crucial for assessing the duration of response to the treatment and overall outcomes.

Who can join the trial?

5 criteria

  • Participants must have at least one measurable lesion. A lesion is an area of abnormal tissue, and it should be measurable according to specific criteria used for evaluating solid tumors.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves. A status of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Participants must have a life expectancy of at least 3 months at the time of the first dose.
  • Participants must be adults, as the study includes age ranges that typically cover adults.
  • Both male and female participants are eligible for the study.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer besides advanced solid tumors cannot participate.
  • Patients who have a type of lung cancer that is not EGFRmt non-small cell lung cancer (NSCLC) or EGFRwt NSCLC cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

BMS-986507 is a new medication being tested to see if it is safe for people with advanced solid tumors, specifically a type of lung cancer. The study aims to find out how much of this medication can be given safely to patients. It is being tested in combination with other treatments to see if it can help treat lung cancer. The goal is to find a safe dose that can be used in a larger group of patients. This medication is being studied in two groups of lung cancer patients: those with a specific type of lung cancer called EGFRmt non-small cell lung cancer (NSCLC) and those with another type called EGFRwt NSCLC.

What is already known about the treatment

BMS-986507 – BMS-986507 is administered as an injection, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials, specifically in a Phase 1/2a study, to assess its safety and effectiveness in treating advanced solid tumors, including certain types of lung cancer. The main goal of this medication is to determine the safest dose that can be used in combination with other treatments for patients with specific lung cancers. At the molecular level, BMS-986507 works by targeting specific pathways in cancer cells to inhibit their growth and spread. It is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that have formed solid masses and have progressed beyond their initial site of origin. These tumors can occur in various organs and tissues, such as the lungs, liver, or pancreas. As they advance, they may invade surrounding tissues and spread to distant parts of the body through the bloodstream or lymphatic system. The progression of these tumors often leads to increased size and number of cancerous cells, which can affect the function of the affected organ. Symptoms vary depending on the location and size of the tumor, and they may include pain, swelling, or organ dysfunction. The growth and spread of these tumors can lead to complications that impact the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514947-27-00Protocol codeCA244-0001Estimated enrolment276 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.