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ODC-IL2 for Advanced or Metastatic Solid Tumors

This study is testing a new drug called ODC-IL2 in adults with advanced or metastatic solid tumors. These are cancers that have spread or are difficult to treat with standard options. ODC-IL2 is given through an IV (into a vein) twice every 28 days. The main goal is to find out how safe ODC-IL2 is and what side effects it might cause. Researchers will also look for any signs that the drug is helping to fight the cancer. Up to 50 patients are expected to join this study. This is a "first-in-human" study, meaning it's one of the first times this drug is being tested in people.

Study design
This is a Phase 1, open-label study, meaning you and your doctors will know you are receiving ODC-IL2. It will involve up to 50 participants and will first find the right dose, then expand to further evaluate safety and activity.
What's involved
You would receive ODC-IL2 through an IV infusion over 60 minutes on Day 1 and Day 15 of each 28-day cycle. The study will monitor for side effects and changes in lab tests.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects and lab changes for 90 days after your last dose of ODC-IL2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06770764

Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Trutino Biosciences Inc.
~50 participants
Updated 2025-01-13 on ClinicalTrials.gov
What's tested:ODC-IL2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLTs)
Measured over 28 days
+2 more outcomes measured

Conditions

Advanced Solid Tumors
Metastatic Solid Tumors

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Solid Neoplasm

NCT06770764

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HonorHealth

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Krystal Martinez
[email protected]
602.358.8300 · ext. 4285
Email the study team

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Eligibility criteria

Inclusion

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) 8. Acceptable renal function:
Absolute neutrophil count ≥ 1500 cells/mm3
Platelet count ≥ 75,000 (plt/mm3)
Hemoglobin ≥ 9 g/dL 10. A negative serum pregnancy test (if a woman of childbearing potential); 11. 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

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 12. 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 13. Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination; 14. Known sensitivity to IL-2 or any of the excipients in ODC-IL2; 15. 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.

What this trial measures

  • Incidence of Dose Limiting Toxicities (DLTs)28 days
  • Incidence of Treatment-Emergent Adverse Events (TEAEs)From the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug

    All AEs will be assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for cytokine release syndrome (CRS) based on investigator assessment.

  • Incidence of changes in clinical laboratory abnormalitiesFrom the first administration of study drug, throughout the course of the study, and for 90 days after the last dose of study drug