Actively Recruiting
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
Led by Trutino Biosciences Inc. · Updated on 2025-01-13
50
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid tumors without available or appropriate standard treatment, or refusal of standard care due to tolerability
- Tumors measurable by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Age 18 years or older
- Signed informed consent approved by Institutional Review Board or Ethics Committee
- Acceptable liver function with bilirubin ≤1.5x upper limit of normal (ULN) or ≤5x ULN if due to Gilbert's Syndrome; AST, ALT, and alkaline phosphatase ≤2.5x ULN, or ≤5x ULN if liver metastases present
- Acceptable kidney function with creatinine clearance ≥50 mL/min
- Acceptable blood counts: absolute neutrophil count ≥1500 cells/mm3, platelet count ≥75,000/mm3, hemoglobin ≥9 g/dL
- Negative pregnancy test if woman of childbearing potential
- Agreement to use adequate contraception during study and for 4 months after last dose for women of childbearing potential and men with partners of childbearing potential
You will not qualify if you...
- New York Heart Association Class III or IV cardiac disease, recent myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG
- Corrected QT interval (QTcF) greater than 470 msec
- Active uncontrolled infections requiring systemic treatment
- Known active brain metastases; stable previously treated brain metastases may be considered
- History of organ transplant
- Use of systemic corticosteroids or immunosuppressive therapy within 7 days before study drug
- Autoimmune diseases requiring systemic immunosuppressive therapy in past 2 years
- Pregnancy or nursing
- Recent cancer treatments within 4 weeks before study entry (6 weeks for certain drugs), except palliative radiation within 1 week
- Inability or unwillingness to comply with study procedures
- Known active HIV, HTLV-1, hepatitis B or C infection unless viral loads undetectable; HIV patients not on stable antiretroviral therapy or with low CD4 counts
- Serious uncontrolled nonmalignant diseases
- Prior IL-2 targeted treatment unless part of tumor infiltrating lymphocyte therapy
- Known sensitivity to IL-2 or ODC-IL2 excipients
- Active treatment with heparin unless transitioned to non-heparin therapy with adequate washout
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
Research Team
K
Krystal Martinez
CONTACT
K
Krishna Patel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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