OncoMatch/Clinical Trials/NCT06770764
Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors
Is NCT06770764 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ODC-IL2 for advanced solid tumors.
Treatment: ODC-IL2 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: IL-2 targeted treatment
Exception: unless given as a part of a tumor infiltrating lymphocyte treatment combination
Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination
Cannot have received: radiation therapy
Exception: palliative radiation for pain allowed within 1 week prior to study entry, but lesion should not be selected as a target lesion for RECIST analysis
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.
Cannot have received: major surgery
Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C).
Cannot have received: chemotherapy
Exception: 6 weeks for nitrosoureas or mitomycin C
Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C).
Cannot have received: investigational therapy
Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C).
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500 cells/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation
Liver function
Bilirubin ≤ 1.5x ULN or ≤ 5x ULN for Gilbert's Syndrome; AST, ALT, and alkaline phosphatase ≤ 2.5x ULN (≤ 5x ULN if liver metastases present)
Cardiac function
NYHA Class III or IV cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia, or evidence of ischemia on ECG excluded; QTcF > 470 msec excluded
Acceptable liver function: Bilirubin ≤ 1.5x ULN or ≤ 5x ULN for Gilbert's Syndrome; AST, ALT, and alkaline phosphatase ≤ 2.5x ULN (≤ 5x ULN if liver metastases present). Acceptable renal function: Calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation. Acceptable hematologic status: Absolute neutrophil count ≥ 1500 cells/mm3; Platelet count ≥ 75,000/mm3; Hemoglobin ≥ 9 g/dL. NYHA Class III or IV cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia, or evidence of ischemia on ECG excluded; QTcF > 470 msec excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth · Scottsdale, Arizona
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