Status and phase
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About
A Phase I, Open-label, Single-center, Dose-escalation and Dose-finding Clinical trial to evaluate the safety, tolerability and pharmacokinetics of MPD-1 in patients with advanced solid tumor
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Within 4 weeks prior to the C1D1, subjects who underwent surgery, chemotherapy (cytotoxic, targeted antitumor drugs), immunotherapy, biological or hormonal therapy, or radiation therapy at areas exceeding 30% of bone marrow for the treatment of this clinical trial's target disease
Participation in other interventional clinical trials (administration of investigational new drugs or use of investigational medical devices) within 4 weeks prior to C1D1
Subjects who are identified with the following comorbidities during screening
The following medical history is identified during screening
Subjects with a history of administration of the following drugs during screening or C1D1
Vaccination against yellow fever within 4 weeks prior to C1D1
Penitoin within 1 week prior to C1D1
G-CSF administration to correct absolute neutrophil count (ANC) levels within 2 weeks prior to C1D1
-- Transfusion of packed red cells or platelets to correct platelets or hemoglobin levels within 2 weeks prior to C1D1
Trastuzumab within 28 weeks prior to C1D1
Pregnant women, nursing mothers, and fertile women with plan for pregnancy
Fertile women or men who do not agree to abstain from sex or perform effective contraception methods for at least 24 weeks after the end of administration* [* Effective Contraception]
Hormone contraception (oral contraceptives, subcutaneous implants, etc.)
Intrauterine device (IUD) or implantation of an intrauterine system (IUS) ③ Infertility procedures or surgeries (vasectomy, bilateral oviduct ligation/excision, hysterectomy, etc.)
Subjects who have a history of allergies to doxorubicin or the excipient of MPD-1 or is suspicious of allergy
Subjects in a state of prohibiting, limiting, or disrupting the assessments specified in the clinical trial (e.g., a history of alcohol or drug abuse within two years prior to C1D1)
Subjects considered as unsuitable for participation in the clinical trial by the investigator (e.g., if the patient's health is unsuitable or participation in this clinical trial is not the best treatment for the patient)
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Central trial contact
Geon Tae Park, Bachelor's degree
Data sourced from clinicaltrials.gov
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