Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS

Prior treatment

• Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment.
• Patients who have not recovered to common terminology criteria for adverse events (CTCAE) Grade ≤ 1 from all side effects of prior therapies except for residual toxicities.
• Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy.
• Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment.

Other illness

• Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.
• Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease.
• Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.
• Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).
• Documented HIV positive.
• Active Hepatitis C or Hepatitis B Viral infection.

• Stage 3 or Stage 4 CRC, NSCLC, or STS who have failed, are ineligible, refused, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy
• Life expectancy of \> 6 months. Only have lesions with the longest diameter of ≤ 5 cm.
• Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm.
• Measurable disease according to RECIST 1.1.
• Age ≥ 18 years.
• ECOG performance status 0-1.
• Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
• Adequate hematological function defined by white blood cell count ≥ 2.5 × 109/L with absolute neutrophil count ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (transfusions allowed on study).
• Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all patients, or for patients with documented metastatic disease to the liver and AST and ALT levels ≤ 5 × ULN. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN.
• Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
• Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion.