None listed
Conditions
Interventions
Drug, Medical Device : Every 3weeks assigned dose of IMP301(Investigational product) will be administered intravenously. After administration, Focused ultrasound system(IMP10, investigational device)
Sponsors
IMGT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women over 19 years of age as of the date of consent. 2) Histologically or cytologically confirmed un-resectable locally advanced and/or metastatic solid tumor patient. Not responding to conventional standard treatment or have disease progression and No other available standard treatment exsist. 3) At least one measurable or non-measurable but evaluable lesion as per RECIST version 1.1 4) Estimated survivor period = 12 weeks 5) ECOG performance status = 1 6) Hematologic, kidney and liver functions. ? ANC = 1,500/mm3 without G-CSF application within 2weeks ? Platelet count = 100,000/mm3 without transfusion within 1week ? Hb = 9 g/dL without transfusion within 1week ? Serum creatinine (or creatinine clearance calculated with Cockcroft-Gault Equation) = 1.5 x ULN (= 60 mL/min) ? Total bilirubin = 1.5 x ULN (In Gilbert’s syndrome = 3.0 x ULN) ? AST = 3 x ULN (confirmed liver-metastasis or liver cell cancer = 5.0 x ULN) ? ALT = 3 x ULN(confirmed liver-metastasis or liver cell cancer = 5.0 x ULN) ? PT (INR) and aPTT = 1.5 × ULN (If on anti-coagulant, within the therapeutic range for intended use of anti-coagulant will be permitted) 7) Able to applicate Focused ultrasound system after IMP301 administration 8) Voluntary participant.
Exclusion criteria
Exclusion criteria: 1) Have any of the following comorbidities ? NYHA class III/IV heart failure ? LVEF < 50% on ECHO or MUGA ? Uncontrolled Hypertension (SBP/DBP = 140/90 mmHg) ? Uncontrolled cardiac arrhythmia ? Uncontrolled chronic systemic infectious disease ? Requiring treatment for pneumonia or respiratory symptoms such as dyspnea, cough, fever. Or other conditions prone to hypoxemia ? Clinically significant symptomatic or uncontrolled central nervous system metastases. (Except anticonvulsants or corticosteroids have been discontinued 2 weeks prior to IMP301 administration and have been clinically or imaging stable for at least 4 weeks. ? Active hepatitis B(HBsAg positive. However, HBsAg-positive patients may participate if they are stable on antiviral therapy.) or hepatitis C(HCV Ab positive. However, if HCV RNA test result is negative, participation is allowed) ? Clinically significant mental illness 2) At the time of the screening visit, have a history of ? Major surgery within 4weeks ? History of clinically significant gastrointestinal bleeding or that would affect pharmacokinetic evaluation within 12 weeks. ? History of drug or alcohol abuse within 12 weeks. ? Acute coronary syndrome within 24 weeks ? Medical history or pre-treatment cytogenetic test results at risk of MDS/AML diagnosis ? Known HIV infection 3) Received any of the following drug/non-drug therapies ? Use of systemic immunosuppressive agents within 2 weeks prior to Baseline (Cycle1Day1 dosing day), except for nasally administered, inhaled, topical, or locally injected (e.g., joint injections) corticosteroids. ? Any of the following anticancer therapies prior to Baseline (Cycle1Day1 dosing day), i. Radiotherapy, chemotherapy, targeted therapy, hormonal therapy, or immunotherapy within 3 weeks (Except point radiation for the purpose of relieving bone pain, bronchial obstruction, skin lesions, etc.). ii. Nitrosoureas or mitomycin-C within 6 weeks. ? Exceeding the cumulative dose of the following Anthracycline series drugs. i. Non liposomal doxorubicin: 250 mg/m2 ii. Liposomal doxorubicin: 300 mg/m2 iii. Epirubicin: 400 mg/m2 4) Focused ultrasound system procedure is not applicable ? Cystic lesion in an organ adjacent to the solid cancer to be treated with Focused ultrasound system. ? Extensive scarring or surgical clips are observed in the pathway of the Focused ultrasound system beam ? Proper ultrasound image for Focused ultrasound system procedure is not available. ? Inability to lie down for the duration of the Focused ultrasound system application. 5) Adverse events after prior chemotherapy that have not recovered to CTCAE grade 1 or baseline status (except for alopecia (any grade), peripheral neuropathy (grade 2 or less), or meeting the eligibility criteria for this study). 6) CTCAE grade 3 or higher Hematologic toxicity after prior chemotherapy exceeding 4 weeks. 7) Predicted hypersensitivity to the major ingredient of IMP301 or any of its analogs, or who have experienced hypersensitivity(CTCAE criteria grade 3 or greater) on any of its analogs. 8) Received an investigational drug or medical device in another clinical trial within 4 weeks prior to IMP301 administration. 9) Pregnant or lactating women 10) Female/male subjects of childbearing potential who plan to become pregnant or who do not agree to practice adequate contraception* after IMP301 administration and for 6 months after termination of treatment. *Adequate contraception: ? Ho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity;Permanent end of Investigational Product administration or dose reduction caused by adverse event.;Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameter;efficacy (1) Following items based on RECIST v1.1 ? Objective response rate, ORR ? Disease control rate, DCR ? Duration of response, DOR ? Progression free survival, PFS 2) Overall survival, OS) | — |
Countries
Korea, Republic of
Contacts
Public ContactJee-Hyun Kim
Seoul National University Bundang Hospital
Outcome results
None listed