Familial Adenomatous Polyposis (FAP) Clinical Trial
The TUPELO clinical trial is an open-label study for people living with familial adenomatous polyposis (FAP).
About the TUPELO study: An open-label
familial adenomatous polyposis clinical trial
The TUPELO study (NCT05552755) is a Phase 1b/2 clinical trial for individuals diagnosed with familial adenomatous polyposis. The trial is evaluating the impact of an investigational drug called REC-4881 on clinical efficacy and safety for those living with familial adenomatous polyposis. Because this is an open-label study, meaning that the research team and you know that you are receiving a study drug, every participant in the trial will receive the active study treatment, REC-4881.
Can I join the
TUPELO study?
You may be eligible to join this familial adenomatous polyposis clinical trial if you meet the following core requirements*:
Age:
You are 18 years of age or older.
Diagnosis:
You have a confirmed diagnosis of familial adenomatous polyposis.
Surgical history:
You have already had surgery to remove a portion or the whole large intestine (an operation known as a colectomy or subtotal colectomy).
Desmoid tumor:
You might also be eligible if you have a Desmoid tumor and you are not receiving treatment for this.
*These are the primary criteria. The study site physician will determine your individual eligibility.
A patient journey through the TUPELO study
You may be assigned to one of two different treatment schedules.
Baseline endoscopy
On treatment
REC-4881—4mg taken orally once a day for 12 weeks
Week 13 endoscopy
Off treatment
12 weeks off treatment
Week 25 endoscopy
Baseline Endoscopy
On Treatment
REC-4881—4mg given orally once a day for 12 weeks
Week 13 Endoscopy
Off Treatment
12 weeks off treatment
Week 25 Endoscopy
Baseline endoscopy
On treatment
REC-4881—4mg taken every day for 7 days, followed by 7 straight days of not taking the study drug. This alternating cycle continues for 24 weeks
Week 25 endoscopy
Off treatment
12 weeks off treatment
Week 37 endoscopy
Baseline Endoscopy
On Treatment
REC-4881—4mg given every day for 7 days, followed by 7 straight days of not taking the study drug. This alternating cycle continues for 24 weeks
Week 25 Endoscopy
Off Treatment
12 weeks off treatment
Week 37 Endoscopy
Find a study location near you
Understanding Familial Adenomatous Polyposis: Causes & Symptoms
What is familial adenomatous polyposis?
Familial adenomatous polyposis is a rare genetic condition that affects how cells grow in the digestive tract. People with familial adenomatous polyposis develop hundreds to thousands of small growths called polyps. While polyps most commonly develop in the colon (the large intestine) and rectum, they can also form in other parts of the gastrointestinal tract, such as the stomach or the small intestine (duodenum).
What causes familial adenomatous polyposis?
Familial adenomatous polyposis is caused by a change (mutation) in the APC gene. When the APC gene isn't working correctly, cells grow uncontrollably, leading to the formation of polyps.
- It is usually inherited: Familial adenomatous polyposis is an "autosomal dominant" condition. This means if one parent has the mutated gene, there is a 50% chance it will be passed on to their child.
- It can also happen spontaneously: In about 20% to 30% of cases, the mutation happens for the first time in an individual with no family history of the condition.
FAQs
What is the purpose of the TUPELO clinical trial?
The TUPELO study is evaluating an investigational drug called REC-4881 open-label to evaluate its impact on clinical outcomes and safety for those living with familial adenomatous polyposis. Specific questions the trial will aim to answer are:
- Is REC-4881 effective in reducing polyp burden (a measure of the total volume of polyps) for patients living with familial adenomatous polyposis?
- Is REC-4881 safe for patients with familial adenomatous polyposis and are there any side effects?
What is the purpose of the DAHLIA clinical trial?
The DAHLIA study is evaluating an investigational drug called REC-1245 to evaluate its impact on clinical outcomes and safety for those living with certain solid tumors and lymphoma. Specific questions the trial will aim to answer are:
- Is REC-1245 safe for patients with cancer and are there any side effects?
- Will REC-1245 show any impact on tumor activity in patients with cancer?
What does an “open-label” trial mean for me?
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-4881.
What would exclude me from taking part in the study?
Various factors about your health may exclude you. The following are some criteria specific to this study:
- REC-1245 is one of a class of drugs called “RBM39 degraders” and if you have received treatment with another RBM39 degrader, you may not be able to take part in the study.
- If you have been diagnosed with significant gastrointestinal malabsorption, meaning your small intestine cannot adequately absorb nutrients from the foods you eat, you would not be able to take part in the study.
What is an investigational drug?
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.
Does my current cancer treatment need to stop if I join 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.
How is REC-4881 taken?
REC-4881 is an oral medication, taken by swallowing a tablet once daily during the treatment period.
What does an “open-label” trial mean for me?
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-1245.
How often do I need to visit the research site?
Participants will need to attend up to 8 on-site visits including screening.
What is an investigational drug?
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.
Can I take part if I don’t live near a research site?
Please contact us using the form above to explore further options.
How is REC-1245 taken?
REC-1245 is an oral medication taken by swallowing a tablet.
What are the risks of taking part in this trial?
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.
How often would I need to visit the research site?
You will visit the research site for the screening visit and the first dosing visit. After that you will return to the research site once every other week for the first 9 weeks, and then once every four weeks for up to 2 years.
How is familial adenomatous polyposis treated now?
There are currently no approved pharmaceutical treatments for familial adenomatous polyposis. Current approaches to manage the condition are monitoring and repeated surgeries.
How long would I be in the study?
Participation in the study will last approximately 2 years.
Do I need to pay to take part in the trial or will I be compensated?
You do not need to pay to take part - there is no cost to participate in the TUPELO study. You will be compensated for your time spent with every visit and reimbursed for certain travel and meal expenses.
Can I take part if I don’t live near a research site?
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.
Do I need health insurance to take part in the trial?
No health insurance is required to take part in the TUPELO study.
What are the risks of taking part in this trial?
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.
Can I join other trials while taking part in the TUPELO familial adenomatous polyposis study?
If you take part in the TUPELO 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.
Do I need to pay to take part in the trial or will I be compensated?
You do not need to pay to take part - there is no cost to participate in the DAHLIA 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.
Do I need health insurance to take part in the trial?
No health insurance is required to take part in the DAHLIA study.
Can I join other trials while taking part in the DAHLIA solid tumor and lymphoma clinical study?
If you take part in the DAHLIA 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.
This product is under investigation and has not been approved by the FDA. The safety and effectiveness of this product has not been established. This information is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Please consult your doctor or get in touch with the sites.
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By entering this site, you certify that you are a resident of the United States. If you are a resident of a country other than the United States, we do not have sites within this trial at your location at this time. Please refer to the rest of our website for where we have current clinical trials.