Actively Recruiting
Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor
Led by Pharosgen Co.,Ltd · Updated on 2025-04-25
24
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 75 years
- Histologically or cytologically confirmed metastatic or unresectable advanced solid tumor
- Tumor progression after all available standard therapies or resistance to standard treatment
- Confirmed KRAS mutation or PTEN loss in tumor tissues with documented records
- No prior administration of anthracycline drugs or anthracene
- At least one measurable or assessable tumor lesion per RECIST 1.1 criteria
- Adequate hematologic, kidney, and liver function based on specified laboratory tests
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of more than 12 weeks
- Recovery from previous therapy-related adverse events to CTCAE version 5.0 grade 1 or below or to C1D1 levels (except hair loss or peripheral neuropathy below grade 2)
- Voluntary written informed consent after understanding study information
You will not qualify if you...
- Surgery, chemotherapy, immunotherapy, biological or hormonal therapy, or radiation therapy involving more than 30% of bone marrow within 4 weeks prior to first treatment
- Participation in other interventional clinical trials involving investigational drugs or devices within 4 weeks prior to first treatment
- Clinically significant symptomatic or uncontrolled central nervous system metastasis (unless stable without corticosteroids for over 2 weeks)
- Heart conditions affecting the trial such as low left ventricular ejection fraction, heart failure, recent myocardial infarction or unstable angina, uncontrolled cardiac dysrhythmia, or coronary artery disease
- History of thrombosis
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Clinically significant ascites
- Infection with hepatitis B virus or hepatitis C virus as determined by serology tests
- Recent chickenpox or varicella zoster infection within 12 weeks
- Uncontrolled active infections including HIV
- Recent vaccination against yellow fever within 4 weeks
- Use of phenytoin within 1 week
- Use of granulocyte colony-stimulating factor (G-CSF) within 2 weeks
- Blood transfusions within 2 weeks
- Use of trastuzumab within 28 weeks prior to first treatment
- Pregnant or nursing women, or fertile individuals planning pregnancy
- Those unwilling to use effective contraception or abstain from sex for at least 24 weeks after treatment
- History of allergy to doxorubicin or MPD-1 components
- History of alcohol or drug abuse within 2 years
- Any other condition deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
G
Geon Tae Park, Bachelor's degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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