Is NCT06770764 recruiting in Scottsdale, AZ?

Yes, NCT06770764 is currently recruiting participants at its Scottsdale, AZ location. This advanced solid tumors clinical trial is actively enrolling qualified participants.

How do I join the advanced solid tumors clinical trial in Scottsdale?

To join this clinical trial in Scottsdale, 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 Scottsdale 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.

Advanced Solid Tumors Clinical Trial in Scottsdale, AZ

About This Advanced Solid Tumors Study in Scottsdale

This is a first-in-human, Phase I, multicenter, open-label, dose escalation study with dose expansion to evaluate the safety and antitumor activity of ODC-IL2 in patients with advanced or metastatic solid tumors. ODC-IL2 is a conditionally activated IL-2 prodrug and will be administered as a single agent via intravenous infusion on Days 1 and 15 of a 28-day cycle. Up to approximately 50 patients will be enrolled in this study.

Sponsor: Trutino Biosciences Inc.

Who Can Participate

Inclusion Criteria

Each patient must meet all the following criteria to participate in the study:

Histologically or cytologically confirmed advanced or metastatic solid tumors, for which no other standard treatment is available or appropriate, or for which the Trutino Biosciences Protocol #: TRT-ODC-IL2-001 Version: 1.0 Date: 20 September 2024 standard of care is refused by the patient due to tolerability or the Investigator believes the patient will not tolerate standard-of-care therapy

Advanced or metastatic tumors measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Life expectancy of at least 3 months;

Age ≥ 18 years;

Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent

Acceptable liver function:

Bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome (familial benign unconjugated hyperbilirubinemia).

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)

Acceptable renal function: • Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation.

Acceptable hematologic status:

Absolute neutrophil count ≥ 1500 cells/mm3

Platelet count ≥ 75,000 (plt/mm3)

Hemoglobin ≥ 9 g/dL

A negative serum pregnancy test (if a woman of childbearing potential);

Women of childbearing potential (WOCBP) and men with WOCBP partners must agree to use adequate contraception (hormonal method of birth control; intrauterine devices or abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose of study drug. Should a female trial participant or a female partner of a male trial participant become pregnant or suspect she is pregnant during the study, the Investigator must be informed immediately.

Exclusion Criteria

New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG)

Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec

Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Known active brain metastases; patients with previously treated, clinically stable, radiologically stable brain metastases (without evidence of progression in 4 weeks) and without the requirement for treatment with corticosteroids in prior 3 weeks may be considered for enrollment after discussion with the Medical Monitor

History of prior organ transplant

Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy within 7 days prior to start of study drug.

History of autoimmune diseases requiring systemic immunosuppressive therapy in the last 2 years

Pregnant or nursing women.

Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Radiation for palliation of pain is allowed within 1 week prior to study entry, but the lesion should not be selected as a target lesion for RECIST analysis.

Unwillingness or inability to comply with procedures required in this protocol

Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV)

Patients with a history of hepatitis B or C are allowed if HBV DNA or HCV RNA are undetectable

Active infection with HIV and CD4+ T-cell count \<350/μL. Patients not on established anti-retroviral therapy for at least 4 weeks and having a detectable HIV viral load

Serious uncontrolled nonmalignant disease (e.g., renal failure, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor

Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination;

Known sensitivity to IL-2 or any of the excipients in ODC-IL2;

Active treatment with heparin or heparin-related therapies, unless the patient can be transitioned to a non-heparin treatment for the clinical condition with an adequate washout prior to enrollment in the study.

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 Scottsdale?

Yes, this clinical trial (NCT06770764) has an active research site in Scottsdale, AZ 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.

Advanced Solid Tumors Treatment Options in Scottsdale, AZ

If you're searching for advanced solid tumors treatment options in Scottsdale, AZ, this clinical trial (NCT06770764) 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 Scottsdale research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced advanced solid tumors 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 advanced solid tumors clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Tumors Clinical Trial in Scottsdale, AZ

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