Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS (NCT05688280) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
United States, France42 participantsStarted 2022-11-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
Exclusion criteria
✕. 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 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.
✕. Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.
✕. 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.
✕. Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).