Is NCT05552755 recruiting in San Diego, CA?

Yes, NCT05552755 is currently recruiting participants at its San Diego, CA location. This familial adenomatous polyposis clinical trial is actively enrolling qualified participants.

How do I join the familial adenomatous polyposis clinical trial in San Diego?

To join this clinical trial in San Diego, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Diego clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Familial Adenomatous Polyposis Clinical Trial in San Diego, CA

Who Can Participate

Inclusion Criteria

Male or female and ≥ 18 years of age

Have provided written informed consent to participate in the study

Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.

Genetic diagnosis of FAP with APC gene mutation (Part 2 only).

Has undergone colectomy or subtotal colectomy

Spigelman Classification Stage II or higher.

Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopies performed at Screening and while on study

Have no significant cardiovascular abnormalities at Screening:

Left ventricular ejection fraction \>50% as determined on screening echocardiogram (ECHO)/ multi-gated acquisition (MUGA)

A QT interval corrected for heart rate using the Fridericia formula (QTcF) \< 450 msec in men and \<470 milliseconds (msec) in women.

Have no significant hematopoietic abnormalities at Screening:

White blood cell count (WBC) ≥ 3,000/cubic millimeters (mm\^3) (non-black populations); 2,700/mm\^3 (black populations)

Platelet count ≥ 120,000/mm\^3

Hemoglobin ≥ 10.0 grams (g)/deciiter (dL)

No history of clinical coagulopathy.

Have no significant hepatic abnormalities at Screening:

Total bilirubin ≤ 1.5 \

upper limit of normal (ULN) (individuals with Gilbert syndrome may be enrolled)

Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 2.0 \

Have no significant renal abnormalities at Screening: serum creatinine ≤ 1.5 times \

Female participants who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours before the first dose of study drug. If the urine test is positive or cannot be confirmed negative, a serum pregnancy test will be required and must be negative for the participant to be eligible.

All participants must be willing to follow the contraceptive guidance in the protocol and must not be lactating or planning to attempt to become pregnant during the study or for a further period of 4 months after the last dose of study drug or impregnate someone during this study or for a further period of 14 weeks after the last dose of study drug.

Absence of gross blood in stool at Screening; red blood on toilet paper only is acceptable.

Participant must be willing to discontinue use of non-steroidal anti-inflammatory agents (NSAIDs) 6 weeks prior to Study Day 1 and remain off NSAIDs throughout the treatment period of the study (use of aspirin ≤ 700 milligrams \[mg\] week is allowed.)

Exclusion Criteria

Has any clinically significant laboratory abnormality, medical or psychiatric illness which, in the opinion of the Investigator, could interfere with the conduct or interpretation of the study or put the participant at risk.

Has had prior pelvic irradiation.

Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.

Has received treatment with other investigational agents within the 4 weeks prior to Study Day 1 or a period during which the investigational agent has not been cleared from the body (that is, at least a period of 5 half-lives, if known), whichever is longer.

Treatment with other FAP-directed drug therapy (such as off-label use of Balsalazide) within 8 weeks of screening endoscopy (Part 2 only) or had a Whipple procedure.

Is currently under treatment for desmoid tumors.

Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1

Use of strong cytochrome P3A (CYP3A) inhibitors or inducers prior to Study Day 1

History of an ongoing or newly diagnosed eye abnormality, including:

Retinal pathologies such as diabetic retinopathy, veno-occlusion, or macular edema

Corneal pathologies such as herpes keratitis, corneal dystrophy, corneal erosions, corneal degeneration, active or recurrent keratitis, or uveitis (intermittent, posterior, and/or panuveitis)

Other clinically significant ophthalmologic abnormalities (for example, retinal detachment) or has findings at Screening. \[Participants with corrected myopia may be enrolled.\]

Has cancer at screening endoscopy in gastrointestinal (GI) tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only).

Has a large polyp (\>1 centimeter \[cm\]) not amenable to complete removal

Has active pancreatitis secondary to pancreatic duct obstruction

Has active gall bladder disease

Is pregnant, lactating or is planning to attempt to become pregnant during this study or within 4 months after the last dose of study drug (women) or is planning to attempt to impregnate someone or donate sperm during the study or within 14 weeks after the last dose of study drug (men).

Has had major surgery prior to Study Day 1

Has an active infection requiring systemic therapy.

Has known hypersensitivity to the study drug or its excipients.

Has a history of alcohol or substance abuse within 1 year prior to screening for study participation, or is currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which, in the opinion of the Investigator, indicates abuse.

Received treatment with another mitogen-activated protein kinase (MEK) inhibitor 8 weeks prior to Screening and throughout the treatment period of the study.

Any of the following known active infections:

Human immunodeficiency virus (HIV) not optimally controlled or treated. Participants with HIV who are on sustained stable antiretrovirals (for \>4 weeks) and have cluster of differentiation (CD)4+ counts ≥ 350 cells/microliter (μL) may be enrolled. No HIV testing is required unless clinically indicated or mandated by local health authority.

Chronic hepatitis B virus (HBV) infection with surface antigen positive: participants with a prior history of treated HBV infection who are hepatitis B surface antigen-negative may be enrolled. No testing is required for hepatitis B unless clinically indicated or mandated by local health authority.

Chronic hepatitis C virus (HCV) infection: untreated or on active treatment. Participants with a prior history of treated HCV infection who are HCV RNA-undetectable may be enrolled. No testing is required for hepatitis C unless clinically indicated or mandated by local health authority.

Has a severe or uncontrolled medical condition (for example, dermatologic disease, etc.) that, in the opinion of the Investigator, would pose a significant clinical risk for the participant.

Use of strong Breast Cancer Resistance Protein (BCRP) or Multidrug Resistance-Associated Protein 2 (MRP2) inhibitors within 14 days of Study Day 1 and throughout the treatment period of the study.

Clinically significant cardiovascular disease ≤ 6 months before first dose

Myocardial infarction or unstable angina

Clinically significant cardiac arrhythmias

Uncontrolled hypertension: systolic blood pressure (SBP) \> 180 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \> 100 mmHg

Pulmonary embolism, symptomatic cerebrovascular events or any other serious cardiac condition (for example, pericardial effusion or restrictive cardiomyopathy)

QTcF prolongation \>450 msec in males and \>470 msec in females at screening or history of long QTc syndrome

Congestive heart failure (New York Heart Association class III-IV)

Myocarditis / clinically significant pericarditis.

Atrial enlargement.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Diego?

Yes, this clinical trial (NCT05552755) has an active research site in San Diego, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Familial Adenomatous Polyposis Treatment Options in San Diego, CA

If you're searching for familial adenomatous polyposis treatment options in San Diego, CA, this clinical trial (NCT05552755) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Diego research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced familial adenomatous polyposis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all familial adenomatous polyposis clinical trials near you to find additional studies recruiting in your area.

Familial Adenomatous Polyposis Clinical Trial in San Diego, CA

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