Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors.

Publication date: Jun 03, 2019

The therapeutic approach taken by trial SAKK 66/17 is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy. Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an injection of IP-001. IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to thermally liberated tumor antigens. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn ‘cold’ tumors into ‘hot’ tumors, inducing a systemic immune response and resulting in shrinkage of the treated tumor including long-term response mediated by the patient’s immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) even those that are outside or distant from the treated area. This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection (Ablation + IP-001) in patients with laser ablation-accessible solid tumors (‘all comers’, Part 1 – safety run in). Further information on safety and tolerability and as well preliminary antitumor activity will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1) and addition, in melanoma patients the anti-tumor activity will be defined as a primary objective (Part 2, Cohort 2). The trial treatment consists of an Ablation + IP-001 in 4-week intervals for up to six scheduled treatments. Thermal ablation will be performed according to the instruction of the medical device and IMP IP-001 will be administered in different dose levels according to the trial design. A follow up of all patients until progression of disease or until start of a subsequent treatment is part of the trial.

Concepts Keywords
Ablation Brain tumor
Alanine Transaminase Treatment of cancer
Allergic Reaction Chemotherapy
Alopecia Radioactivity
ALT Radiobiology
Androgens Radiation therapy
Antimicrobial Medical physics
Arrhythmias Antineoplastic drugs
Aspartate Transaminase Oncology
Aspirin Clinical medicine
AST Health
Atrial Fibrillation Medicine
Autoimmune Immunotherapy
Bicalutamide Radiotherapy
Bilirubin Laser ablation
Bone Marrow Chemotherapy
BRAF Immunosuppressive therapy
BRAF Inhibitor Indicative active disease
Brain Imaging Accessible solid tumors
Brain Tumors Suitable imaging
Cardiovascular Chemical castration
Castrated MRI
Chemical Castration Antibodies
Chemotherapy Chemotherapy
CKD Laser
Clinical Examination Contraception
Coagulation Advanced recurrent melanoma
Cohort Intended trigger tumor
Concurrent Supraventricular tachycardia
Congestive Heart Failure Risk skin necrosis
Contraception Preliminary anti tumor
Corticosteroids Unstable angina
Crustaceans G systemic lupus
Cytologically Alopecia
EGFR Anti tumor
Formula Thermally liberated tumor
Gonadotropin Measurable evaluable disease
HCG Uncontrolled hypertension
Hemoglobin Exception atrial fibrillation
Heparin Viral infection
Histologically
HIV
Hormone
Hypertension
ICH
Immune Response
Immunodeficiency
Immunosuppressive Therapy
Immunotherapy
Indicative
Informed Consent
Intravenous
Investigational Drug
Lactating
Laser Ablation
LDH
Leptomeningeal
Lesion
Liver
Lupus
Luteinizing Hormone
Lymph Nodes
Malignancy
Malignant
Melanoma
Metastasis
Metastatic Tumor
Methotrexate
Mitomycin
Molecular Weight
Monoclonal Antibodies
MRI
Mutant
Myocardial Infarction
Neutrophil
Nilutamide
Palliative
PET CT
Platelet
Prednisolone
Pregnancy Test
Prostate
QT Prolongation
Radiotherapy
Renal Function
Sarcoma
Serum
Shellfish
Skin Necrosis
Soft Tissue Sarcoma
Solid Tumor
Sperm
Subcutaneous Tissue
Subcutaneously
Swiss
Swiss Law
Systemic Infection
Tolerability
Tumor
Tumor Antigens
Unstable Angina
Viral Infection
Virus
Vitamin
Warfarin

Semantics

Type Source Name
gene UNIPROT BRAF
gene UNIPROT SLC17A5
drug DRUGBANK L-Alanine
gene UNIPROT CYREN
disease DOID Sarcoma
gene UNIPROT FASTK
disease DOID cancer
gene UNIPROT OPN1MW
gene UNIPROT OPN1MW2
gene UNIPROT OPN1MW3
gene UNIPROT COL4A2
gene UNIPROT GOLGB1
disease MESH ICH
gene UNIPROT BRAP
gene UNIPROT IMPA1
disease DOID melanoma
pathway BSID Melanoma
disease MESH melanoma
disease MESH soft tissue sarcoma
disease MESH Tumors
gene UNIPROT MAGEE1
gene UNIPROT TFPI
disease DOID Chronic Kidney Disease
disease MESH Chronic Kidney Disease
gene UNIPROT EGFR
disease MESH Renal
disease MESH metastasis
drug DRUGBANK Chorionic Gonadotropin (Human)
gene UNIPROT CGA
disease MESH Men
gene UNIPROT ELL
disease MESH Malignant primary brain tumors
drug DRUGBANK Mitomycin
disease MESH alopecia
disease DOID alopecia
disease MESH prostate cancer
disease DOID prostate cancer
pathway BSID Prostate cancer
drug DRUGBANK Bicalutamide
drug DRUGBANK Nilutamide
drug DRUGBANK Lutropin alfa
drug DRUGBANK Prednisolone
drug DRUGBANK Methotrexate
drug DRUGBANK Phylloquinone
drug DRUGBANK Phenprocoumon
drug DRUGBANK Warfarin
drug DRUGBANK Heparin
drug DRUGBANK Acetylsalicylic acid
disease MESH bleeding
disease MESH cardiovascular disease
disease MESH congestive heart failure
disease DOID congestive heart failure
disease MESH unstable angina pectoris
disease MESH myocardial infarction
disease DOID myocardial infarction
disease MESH atrial fibrillation
disease DOID atrial fibrillation
disease MESH supraventricular tachycardia
disease MESH hypertension
disease DOID hypertension
disease MESH chronic Hepatitis C
disease DOID chronic Hepatitis C
disease MESH Hepatitis B
disease DOID Hepatitis B
pathway BSID Hepatitis B
disease MESH Viral infection
disease DOID Viral infection
disease MESH infection
disease MESH autoimmune disease
disease DOID autoimmune disease
disease DOID lupus
disease MESH allergic reaction
disease DOID crabs
disease MESH familial
disease MESH complications
gene UNIPROT NR4A2
gene UNIPROT ALG3

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