Solid Tumor including Small Cell Lung Cancer Clinical Trial

The ENLYGHT study is evaluating an investigational drug called REC-4539 on its impact on safety for patients and efficacy against specific solid tumors, including finding the right dose amount. Questions the trial will aim to answer are:

• Is REC-4539 safe for patients with solid tumors including small cell lung cancer and are there any side effects? 
• Will REC-4539 show any impact on tumors in patients with selected solid tumors?
• What is the best dose(s) of REC-4539 that demonstrates efficacy while managing any side effects? 

Various factors about your health may exclude you. The following are some criteria specific to this study:

• If you have any medical or mental health condition that the study doctor feels could put your safety at risk or make it difficult for you to complete study visits, you would not be able to take part in the study.
• If you have cancer that has spread to the brain or spine and is causing symptoms, or if your brain metastases have required steroids, seizure medication, or new treatments within the last month, you would not be able to take part in the study.
• If you have an active, serious infection that has required treatment with antibiotics, antivirals, or antifungal medicine within 7 days of the study start date, you would not be able to take part in the study.
• If you have significant heart problems or abnormalities, you would not be able to take part in the study.
• If you have had a major surgery within the 28 days leading up to the start of the study treatment, you would not be able to take part in the study.

Yes, some of your current cancer treatment may need to stop to take part in this study in order to understand what impact this investigational drug might have on your cancer. Please consult with the study site for more information.

In this trial, "open-label" means there is no placebo, and all study participants and doctors will know what you are taking. Every person who is eligible and enrolls in the study will receive the active investigational medication, REC-4539.

An investigational drug (also called an experimental treatment) is a substance that has not been approved by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for use by the general public. Its safety and efficacy have not been established.

In certain types of solid tumors, like small cell lung cancer or high-grade neuroendocrine tumors, the body produces abnormal cells that grow and divide uncontrollably. These cells are "stuck" in a fast-growing state because a specific protein called lysine-specific demethylase 1 (or LSD1) acts as a silencer, turning off the internal signals that would normally tell a cell to stop dividing and mature. REC-4539 is a type of LSD1 inhibitor, meaning that it has the potential to block LSD1 and turn those maturity signals back on. We are studying REC-4539 to see if blocking LSD1 has an effect on the growth of the cancer cells.

REC-4539 is an oral medication taken by swallowing a tablet.

Participants who are eligible to join the study will visit the research site during the screening, treatment, safety follow-up, and disease progression follow-up (if applicable) periods.

Participation in the study will last up to approximately 2 years. At any time, once an enrolled participant's cancer gets worse or a participant experiences any severe side effects from treatment, they may be taken off study treatment.

If you are interested in enrolling in the trial, please contact your nearest study site or contact us to find a site nearest to you. You would then contact that site to discuss your options for participation.

This clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to ask questions and learn about these risks, so you can decide if the study is right for you.

You do not need to pay to take part - there is no cost to participate in the ENLYGHT study. If you are enrolled in the trial, you will be compensated for your time spent with every visit and reimbursed for certain travel and meal expenses.

No health insurance is required to take part in the ENLYGHT study.

If you take part in the ENLYGHT study, you cannot join another study at the same time where you would receive an investigational drug. You can take part in an observational study (a study where doctors track your health and symptoms over time without changing your treatment or introducing experimental treatments) that does not require you to take an investigational drug from that study.