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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06770764 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior IL-2 targeted treatment, radiation therapy, major surgery disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify