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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunophotonics, Inc.

Criteria

Inclusion Criteria:

1. 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

2. Life expectancy of > 6 months. Only have lesions with the longest diameter of ≤ 5 cm.

3. Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm.

4. Measurable disease according to RECIST 1.1.

5. Age ≥ 18 years.

6. ECOG performance status 0-1.

7. Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.

8. 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).

9. 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.

10. Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).

11. Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion.

Exclusion Criteria:

1. Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.

2. Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease.

3. Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment.

4. 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.

5. Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.

6. Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy.

7. Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment.

8. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).

9. Documented HIV positive.

10. Active Hepatitis C or Hepatitis B Viral infection.