Colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients MedDRA version: 21.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10075333 Term: Soft tissue sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Cla
Conditions
Interventions
Product Name: IP-001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
Current Sponsor code: IP-001
Other descriptive name: N-Dihydrogalactochitosan
Concentration unit: mg/ml milligr
Sponsors
Immunophotonics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent from patient in accordance with local regulatory and/or national laws and ICH/GCP regulations before registration and before any study specific activity is performed. 2.Patients with either histologically or cytologically confirmed Stage 3 or Stage 4 CRC, NSCLC, or STS who a.have failed, are ineligible, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy, b.have a life expectancy of > 6 months, c.only have lesions with the longest diameter of = 5 cm, and d.would benefit from RFA alone as part of routine care or have a treatment plan that includes RFA alone. 3.Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm and located such that it can be treated without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue. 4.Measurable or evaluable disease, determined with the most suitable imaging method, either computed tomography (CT) or magnetic resonance imaging (MRI), 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, hemoglobin = 9 g/dL, and coagulation (partial thromboplastin time [PPT] = 25.0-33.0 seconds, activated partial thromboplastin time [aPTT] depends on local methodology and reference standards, and international normalized ratio [INR] = 0.8-1.2) (transfusions allowed on study if received at least 14 days prior to assessing hematological samples). 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.Women with childbearing potential are using highly effective contraception (achieve a failure rate of less than 1% per year in accordance with the national guidance), are not pregnant or lactating and agree not to become pregnant during trial treatment and for an additional 187 days after the last dose of investigational drug. Women of childbearing potential must have a negative serum human chorionic gonadotropin pregnancy test before inclusion. 12.Men agree not to donate sperm or to father a child during trial treatment and until 97 days after the last dose of investigational drug. 13.In France, the patient must be affiliated to a social security system, and currently benefit from the corresponding rights and cover, in accordance with French Public Health Code. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 as ascertained by clinical examination and brain imaging (MRI or CT). 3.Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days (7 days for single fraction of palliative radiotherapy, 42 days for nitrosoureas or mitomycin C) 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, such as alopecia or Grade 2 neuropathy, which do not pose an ongoing medical risk. 5.Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, prostate, or breast, or has undergone potentially curative therapy with no evidence of disease recurrence for at least 3 years prior to the first trial treatment and no additional therapy is required or anticipated to be required during the trial period. Other exceptions may be considered with Sponsor consultation. 6.Concomitant treatment with systemic corticosteroids (daily dose not to exceed 10 mg prednisolone or equivalent) or other immunosuppressive therapy (e.g., methotrexate). 7.Oral anti-coagulation with vitamin K antagonists (e.g., phenprocoumon, warfarin) and heparin, including therapeutically dosed low molecular weight heparins, which cannot be stopped 24 hours prior to trial treatment (low-dose aspirin allowed) and bleeding diathesis. 8.Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV), unstable angina pectoris, history of myocardial infarction within the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension. 9.Known history of human immunodeficiency virus or active chronic Hepatitis C or Hepatitis B Viral infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment. 10.Serious autoimmune disease (e.g., systemic lupus erythematosus) which is judged to reduce an anti-tumor immune response. 11.Any other serious underlying medical (e.g., patients who have a non-controlled infection that requires systemic therapy), psychological, familial or geographical condition, which in the judgment of the Investigator may limit compliance with the planned staging, treatment and follow-up, or place the patient at high risk from treatment-related complications. 12.Patient not eligible for general endotracheal anesthesia, if necessary, for thermal ablation treatment. 13.Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research, persons who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice), and persons = 18 years old unable to express consent and who is not subject to a legal protection measure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine safety and tolerability of 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor.;Secondary Objective: The secondary objective is to determine anti-tumor activity of 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor. The exploratory objectives of the trial are translational research to: • Determine the presence and nature of the immune response elicited by 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor • Determine the formation of anti-drug antibodies (ADA) by 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor • Determine the correlation between a tumor market and response to 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor • Determine the pharmacokinetics of 1.0% IP-001 for Injection;Primary end point(s): The primary endpoint will be assessed by adverse events (AEs), vital sign measurements, physical examination findings, Eastern Cooperative Oncology Group (ECOG) performance status, pulmonary function, clinical laboratory assessments, and electrocardiogram (ECG);Timepoint(s) of evaluation of this end point: From start of trial treatment until 90 days after the last trial treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Disease control according to Response Evaluation Criteria in Solid Tumors for immune-based treatments (iRECIST) (iDC) • Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC) • Objective response according to iRECIST (iOR) • Duration of response according to iRECIST (iDOR) • Progression-free survival according to iRECIST (iPFS) • Objective response according to RECIST 1.1 (OR) • Duration of response according to RECIST 1.1 (DOR) • Progression-free survival according to RECIST 1.1 (PFS) • Time to response according to iRECIST 1.1 (iTTR) • Time to response according to RECIST 1.1 (TTR) • Disease-free survival (DFS) • Overall survival (OS) • OR of the injected lesions according to RECIST 1.1 • OR of the non-injected lesions according to RECIST 1.1 • iOR of the injected lesions according to iRECIST • iOR of the non-injected lesions according to iRECIST;Timepoint(s) of evaluation of this end point: For 12 weeks. | — |
Countries
France, Germany, Switzerland, United Kingdom
Contacts
Public ContactVP, Regulatory and Clinical Affairs
Immunophotonics Inc.
Outcome results
None listed