Informations générales (source: ClinicalTrials.gov)
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase 1b/2a Trial in Colorectal Cancer, Non-small Cell Lung Cancer, and Soft Tissue Sarcoma Patients (INJECTABL-1)
Interventional
Phase 1/Phase 2
Immunophotonics, Inc. (Voir sur ClinicalTrials)
novembre 2022
février 2025
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Thierry DE BAERE | 06/03/2024 09:47:59 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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.