Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IMP301 in Patients with Advanced/Metastatic Solid Tumors

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0009135
• Lead Sponsor: IMGT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity;Permanent end of Investigational Product administration or dose reduction caused by adverse event.;Adverse Event

Secondary Outcome Measures

Name	Time	Method
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)