Actively Recruiting
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
Led by Pharosgen Co.,Ltd · Updated on 2025-04-25
24
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I, open-label clinical trial at a single center to study MPD-1 in patients with advanced solid tumors. This trial aims to evaluate the safety, tolerability, and how the body processes MPD-1, a prodrug that targets KRAS mutant or PTEN loss cancers. The study focuses on patients who have metastatic or unresectable tumors unresponsive to existing standard therapies. Participants will receive MPD-1, which uses Doxorubicin to target specific cancer mutations. The trial involves dose escalation to find the maximum tolerated dose and the recommended dose for further studies. Treatment duration and response will be closely monitored over an 18-week period, with pharmacokinetic measurements taken from the first treatment day through one week afterward. During the trial, participants will undergo regular assessments including laboratory tests to check blood counts and organ function, as well as electrocardiograms to monitor heart activity. Researchers will evaluate treatment-related side effects and drug levels in the body. The study involves ongoing monitoring from the first dose up to 18 weeks to determine safety and dosing, with participants expected to have measurable or assessable tumors and adequate organ function before enrollment.
CONDITIONS
Brief 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/inadequate response to them
- Confirmed KRAS mutation or PTEN loss in tumor tissues with documented record
- No prior administration of anthracycline drugs and/or anthracene
- At least one measurable or assessable lesion according to RECIST 1.1 criteria
- Appropriate hematologic, kidney, and liver function as per lab tests before screening and first treatment day
- ECOG performance status of 0 or 1
- Expected survival period of more than 12 weeks
- Recovery from previous therapy-related adverse events to grade 1 or below per CTCAE version 5.0
- Voluntary agreement and signed informed consent
You will not qualify if you...
- Surgery, chemotherapy, immunotherapy, biological or hormonal therapy, or radiation therapy exceeding 30% of bone marrow within 4 weeks before first treatment
- Participation in other interventional clinical trials within 4 weeks before first treatment
- Clinically significant symptomatic or uncontrolled central nervous system metastasis unless stable without recent corticosteroids
- Heart conditions affecting the study, including low ejection fraction, heart failure, recent heart events, or uncontrolled cardiac arrhythmia
- History of thrombosis
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Clinically significant ascites
- Infection with hepatitis B or C virus as confirmed by serology
- Recent chickenpox or varicella zoster infection within 12 weeks
- Uncontrolled active infections including HIV
- Use of certain drugs or vaccines within specified periods before first treatment
- Pregnant or nursing women and those planning pregnancy
- Fertile men or women unwilling to use effective contraception during and for 24 weeks after treatment
- Allergy history to doxorubicin or MPD-1 components
- History of alcohol or drug abuse within 2 years prior to first treatment
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive MPD-1 treatment to evaluate safety, tolerability, and pharmacokinetics.
Visits throughout treatment period including assessments on Cycle 1, Day 1 and Day 8
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
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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