Is NCT07252479 recruiting in Orlando, FL?

Yes, NCT07252479 is currently recruiting participants at its Orlando, FL location. This solid tumors (phase 1) clinical trial is actively enrolling qualified participants.

How do I join the solid tumors (phase 1) clinical trial in Orlando?

To join this clinical trial in Orlando, 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 Orlando 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.

Solid Tumors (Phase 1) Clinical Trial in Orlando, FL

About This Solid Tumors (Phase 1) Study in Orlando

The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are: Which dose(s) of AN9025 are safe and tolerable for use in evaluating anti-tumor activity in participants with Rat Sarcoma oncogene (RAS) mutated solid tumors? What medical problems do participants have when taking AN9025? Participants will: Take AN9025 by mouth every day or once a week until their disease progresses, they experience severe ill side effects from taking the drug, or withdraw from the study due to their own choice or as recommended by their physician. Visit the clinic 3-4 times during the first 21 days of treatment for study testing, blood draws and tumor tissue sample collection (if needed). The blood draws will be used to check drug levels in the participants blood for research purposes. Visit the clinic every 21 days for checkups and tests and monitoring of participant progress. Return to the clinic at 14 and 30 days after AN9025 treatment is stopped. Participants will be contacted every 3 months to check on the participants disease status and general well being. Participants may also partake in a food effect study, where the effect of eating is studied to see if there is any effect on AN9025 in the body.

Sponsor: Adlai Nortye Biopharma Co., Ltd.

Who Can Participate

Inclusion Criteria

Aged ≥18 years old at the time of informed consent.

Able to provide informed consent voluntarily before any study-related activities and according to local guidelines.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator.

Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.

Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory. Note: Participants with melanoma who have documented loss-of-function NF1 mutation and wild type KRAS/NRAS/HRAS/BRAF are also eligible for the backfill of Part 1 cohorts QD, QW.

Have consented to provide archival tumor tissue collected within 5 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.

Part 1 Dose-Escalation and Part 2 Food Effect Assessment: cancers including, but not limited to:

Pancreatic ductal adenocarcinoma (PDAC)

Colorectal cancer (CRC)

Non-small cell lung cancer (NSCLC)

Cutaneous melanoma

Biliary tract cancer (BTC)

Part 3 Dose-Expansion: Cohort 3A: RAS-mutated solid tumors (2L/3L)

Histologically or cytologically confirmed advanced or metastatic disease

Participants must not have tumors previously tested positive for targetable oncogenic driver mutations including Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), B-Rapidly Accelerated Fibrosarcoma (BRAF), RET, and ROS1

Participants must have received 1 or 2 prior lines of systemic therapy which include prior immune checkpoint inhibitor and platinum chemotherapy administered either concurrently or sequentially, and have not received docetaxel previously

Participants must be refractory to anti-PD-1/PD-L1 therapy.

Adjuvant therapy or multimodal therapy with curative intent is considered prior therapy if disease progression occurred or treatment completion was within 6 months of first dose of AN9025.

Participants must not have tumors previously tested positive for Class I BRAF mutations i.e. V600X.

Have adequate organ functions prior to enrollment:

ANC: \>= 1.5 x 10\^9/L

Platelets: \>= 100x 10\^9/L

Hemoglobin: \>= 9.0 g/dL

AST and ALT: \<= 2.5 x Upper Limit of Normal (ULN) or ,+ x ULN if liver metastases are present

Total bilirubin: \<= 1.5 x ULN

Creatinine clearance (CrCl): CrCl \>= 50 ml/min as determined by Cockcroft-Gaulat formula

International Normalized Ratio (INR) or prothrombin (PT) time or activated partial thromboplastin time (aPTT): PT or aPTT \<= 1.5 x ULN or INR \< 1.5

Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1 (except for alopecia, and endocrinopathies that are managed with replacement therapy), and all clinically significant toxicities from prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy to ≤ Grade 1 prior to enrollment.

Corrected QT interval (QTc) ≤ 470 msec for females and ≤ 450 msec for males per the Fridericia's Formula (QTcF).

Able to swallow oral medication and comply with study requirements.

Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.

Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 14 days prior to the first dose of the study treatment.

Exclusion Criteria

Participants meeting any of the following criteria will not be eligible for participation in the study.

Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Have tumors previously tested positive for Class I BRAF mutations i.e. V600X.

Prior treatment with a pan-RAS(ON) inhibitor, ) except for participants enrolled in the backfill cohorts who have experienced radiological or clinical disease progression on prior pan-RAS(ON) inhibitor therapy.

Gastrointestinal conditions that may interfere with drug absorption (e.g., malabsorption syndrome, chronic nausea/vomiting, active inflammatory bowel disease).

Have a serious concomitant systemic disorder that, in the judgment of the Investigator, would compromise the participant's ability to adhere to the protocol, such as the following:

Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.

Participants with evidence of active Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody)

Active tuberculosis, fungal infection

Active infection requiring intravenous antibiotic therapy. Use of oral antibiotics for minor infections (e.g., uncomplicated UTI or URI) is permitted if clinically stable, at the Investigator's discretion

The participant has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD), severe dyspnea at rest, or requiring oxygen therapy.

Prior or second concurrent primary malignancies that, in the judgment of the Investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the Investigator, or malignancies that don't need treatment (i.e., small renal cell carcinoma \[RCC\] and localized prostate cancer) are eligible for this study.

Moderate or severe cardiovascular disease, such as the following:

congestive heart failure

New York Heart Association Class III/IV heart disease

unstable angina pectoris

myocardial infarction or cardiovascular event within the last 6 months before enrollment

valvulopathy that is severe, moderate, or deemed clinically significant

arrhythmias that are symptomatic or require treatment (not including Participants with rate-controlled supraventricular tachycardia)

a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT syndrome)

require the use of concomitant medications that prolong the QT/QTc interval

Have symptomatic central nervous system (CNS) malignancy or metastasis.

Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN9025. Plan to be breastfeeding from the initial dose of study treatment or within 6 months following the last dose of AN9025.

Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.

Use of other herbal supplements, traditional medicines, or prescription medications that are known or suspected to interact with the investigational product or effect disease treatment/side effect management, as determined by the study Investigator.

Known allergic reaction against any of the components of the study treatments.

Current use of drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications.

Current use of drugs known to be of P-glycoprotein (P-gp) inhibitors.

Participants who are unable to discontinue proton pump inhibitors (PPIs) for at least 5 days prior to the first dose of AN9025, or unable to abstain from PPI use throughout the study treatment period.

Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and Investigator's knowledge.

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 Orlando?

Yes, this clinical trial (NCT07252479) has an active research site in Orlando, FL 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.

Solid Tumors (Phase 1) Treatment Options in Orlando, FL

If you're searching for solid tumors (phase 1) treatment options in Orlando, FL, this clinical trial (NCT07252479) 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 Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced solid tumors (phase 1) 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 solid tumors (phase 1) clinical trials near you to find additional studies recruiting in your area.

Solid Tumors (Phase 1) Clinical Trial in Orlando, FL

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