Not recruiting

Study of PRT3789 and Pembrolizumab for Patients with Advanced Solid Tumors, Esophageal Cancer, or NSCLC with SMARCA4 Mutation

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment combination for patients with certain types of cancer. The diseases being studied include non-small cell lung cancer (NSCLC), esophageal cancer, and other advanced or metastatic solid tumors that have a specific genetic change known as a SMARCA4 mutation. The treatment being tested combines two medications: PRT3789 and pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is a type of medication that helps the immune system fight cancer, while PRT3789 is a new drug being investigated for its potential to work alongside pembrolizumab.

The purpose of this study is to evaluate how safe and effective the combination of PRT3789 and pembrolizumab is for patients with these specific types of cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how patients respond to the treatment over time, looking at factors such as any side effects they experience and how well the treatment works in controlling the cancer.

Throughout the study, researchers will collect information on the safety of the treatment and how well it helps in reducing or controlling the cancer. This includes observing any changes in the size of the tumors and the overall health of the participants. The study aims to provide valuable insights into whether this combination of medications can offer a new treatment option for patients with these challenging types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes checking your age, organ function, and medical history. You will also need to provide a sample of your tumor tissue, if available.
Step 3
Treatment plan
You will receive two medications: pembrolizumab and PRT3789. Both are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.
The specific dosage and frequency of these medications will be determined by the study team based on your individual needs and the study protocol.
Step 4
Regular visits
You will have regular visits to the study site for treatment and monitoring. These visits will include physical exams, blood tests, and imaging studies to assess your response to the treatment.
The frequency of these visits will be explained to you by the study team.
Step 5
Monitoring and reporting
Throughout the study, you will be monitored for any side effects or adverse reactions to the treatment. It is important to report any new symptoms or changes in your health to the study team immediately.
The study team will also track the effectiveness of the treatment in managing your condition.
Step 6
End of treatment
At the end of the treatment period, a final assessment will be conducted to evaluate your overall response to the study medications.
You will be informed about the next steps and any follow-up care that may be necessary.

Who can join the trial?

13 criteria

Patients must be 18 years or older at the time they agree to participate.
Patients must have adequate organ function, which means their blood, kidneys, liver, and blood clotting are working well.
Patients must be willing and able to attend all scheduled visits, follow the treatment plan, undergo laboratory tests, and follow lifestyle guidelines, including using contraception if required. They must also agree to participate by signing a consent form.
For the initial safety phase of the study, patients must have an advanced, recurring, or spreading solid tumor confirmed by tests, with any mutation in the SMARCA4 gene found in tumor tissue or blood, or a lack of SMARCA4 protein (also known as BRG1).
For the main part of the study, patients must have advanced, recurring, or spreading esophageal cancer or non-small cell lung cancer (NSCLC) confirmed by tests, with a harmful mutation in the SMARCA4 gene.
Patients must meet at least one of the following conditions regarding previous treatments:
- They did not respond to previous anti-PD-1/PD-L1 therapy, which is a type of cancer treatment, and their disease got worse.
- They initially responded to anti-PD-1/PD-L1 therapy but their disease got worse within 6 months after treatment.
- They received standard treatment but not anti-PD-1/PD-L1 therapy because their tumor did not have PD-L1 protein.
- They stopped anti-PD-1/PD-L1 therapy for reasons other than disease worsening, and their disease got worse more than 6 months after stopping.
- For the initial safety phase, patients must have a disease that can be measured or evaluated by the study team. For the main study, patients must have a disease that can be measured, even if it was previously treated with radiation and has shown signs of worsening.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
- Patients must be willing and able to provide a sample of their tumor tissue, either from previous tests or a new sample if previous samples are not available.
- Patients must have controlled blood pressure, with or without medication, defined as less than 160/100 mmHg at the start of the study, and no changes in blood pressure medication within one week before starting the study.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who are currently pregnant or breastfeeding are not eligible.
Individuals with other active cancers, except for non-melanoma skin cancer, are excluded.
Patients with uncontrolled infections are not allowed to join the study.
Those who have had a major surgery within the last 4 weeks cannot participate.
Patients with significant heart problems, such as heart failure or a recent heart attack, are excluded.
Individuals with a history of certain lung diseases, like interstitial lung disease, are not eligible.
Patients who have received another investigational drug within the last 4 weeks are excluded.
Those with a known history of HIV, hepatitis B, or hepatitis C infections cannot participate.
Patients with any condition that, in the opinion of the study doctor, makes participation unsafe are not eligible.

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Verified sites

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

Goethe University Frankfurt
Verified
Frankfurt, Germany
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

Trial locations

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Investigated drugs

PRT3789
is an experimental medication being studied for its potential to treat certain types of cancer. It is specifically designed to target tumors that have a mutation in a gene called SMARCA4. This mutation can make the cancer more aggressive, and PRT3789 aims to interfere with the cancer cells' ability to grow and spread. In this clinical trial, researchers are testing how safe and effective PRT3789 is when used in combination with another medication.
Pembrolizumab
is a type of cancer treatment known as immunotherapy. It works by helping the body's immune system recognize and attack cancer cells. Pembrolizumab is already used to treat various types of cancer, including some forms of lung cancer and esophageal cancer. In this study, it is being combined with PRT3789 to see if the two medications together can more effectively treat tumors with the SMARCA4 mutation. Researchers are interested in understanding how well this combination works and how patients tolerate it.

What is already known about the treatment

PRT3789 – PRT3789 is administered in combination with pembrolizumab, typically through intravenous infusion, which means it is delivered directly into the bloodstream. This medication is currently being studied in clinical trials, focusing on its safety and effectiveness for treating advanced or metastatic solid tumors, particularly those with a SMARCA4 mutation, including non-small cell lung cancer (NSCLC) and esophageal cancer. The main therapeutic goal is to help the immune system better recognize and attack cancer cells. PRT3789 works at the molecular level by targeting specific mutations in cancer cells, potentially disrupting their growth and survival. It is classified as an investigational drug, meaning it is still under study and not yet approved for general medical use.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs. As the cancer advances, it can metastasize to distant parts of the body, affecting overall health and organ function.
Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation
This condition involves solid tumors that have spread beyond their original site and possess a specific genetic mutation known as SMARCA4. These tumors can originate in various organs and tissues, and the SMARCA4 mutation can influence their growth and behavior. As the disease progresses, the tumors may grow larger and spread to other parts of the body. The presence of the SMARCA4 mutation can affect the tumor's response to certain biological processes. This mutation may also impact the tumor's ability to evade the immune system.
Esophageal Cancer
Esophageal Cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the inner lining of the esophagus and can grow outward through the other layers. As the cancer progresses, it can cause narrowing of the esophagus, leading to difficulty swallowing. The disease may spread to nearby lymph nodes and other organs, such as the liver or lungs. Over time, the cancer can invade deeper tissues and potentially metastasize to distant sites in the body.