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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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
Hopital Tenon Paris France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Hospital Universitario 12 De Octubre Madrid Spain
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cnmvsi Lvxa Bvqjhj Lyon France
Lxjyu Usvmjjdjnejy Mifveky Cvmytrz (zfapb Leiden The Netherlands
Iyivjskj Cqhgyn Dhxzypxclxpmfnjyd L'hospitalet De Llobregat Spain
Hpiqkvok Uyledfgczsols Rqfnthzy Dk Mdreda Malaga Spain
Itcfozri Bmtvjudw Bordeaux France
Alkmmammve Pyfmbtmm Hqtpxvuc Dv Muuvgfude Marseille France
Hhrmofku Vgpt didxuszj Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Recruiting
25.01.2025
Italy Italy
Recruiting
25.01.2025
Spain Spain
Recruiting
25.01.2025
The Netherlands The Netherlands
Recruiting
25.01.2025

Trial locations

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.

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 ID:
2024-514947-27-00
Protocol code:
CA244-0001
Trial Phase:
Human Pharmacology (Phase I) – Other

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