Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-75
SponsorPharosgen Co.,Ltd
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
19 to 75 years of age
A histologically or cytologically confirmed, metastatic or unresectable advanced solid tumor patient who has used all available existing standard therapy but tumor progression is confirmed and further treatment tool is absent, or patient showing resistant or inadequate to standard therapy.
KRAS mutation or PTEN loss is confirmed in tumor tissues prior to screening, and there is a documented record of this
Patients without the history of administration of anthracycline drugs and/or anthracene
Disqualifiers
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
Heart disease that could affect this clinical trial (left ventricular ejection fraction (LVEF) <50%, congestive heart failure with New York Heart Association (NYHA) class II or higher, history of myocarditis, myocardial infarction or unstable angina within 24 weeks before C1D1, uncontrolled cardiac dysrhythmia by appropriate medication, coronary artery disease, etc.)
Trial design
Design model
Sequential
Treatments tested in this trial
MPD-1
DrugIt is a prodrug that uses Doxorubicin to target KRAS mutant/ PTEN loss advanced cancer.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: MPD-1 treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) Determination
Number of participants experiencing dose-limiting toxicities (DLTs) during the DLT observation period (3 weeks, 1 cycle) following administration of MPD-1, as defined by CTCAE v5.0 criteria. • Unit of Measure: Number of participants with DLTs
Time frame
From first treatment to the end of treatment at 18 weeks2
Incidence of Treatment-Related Adverse Events
Number of participants experiencing treatment-related adverse events, as assessed by CTCAE v5.0. • Unit of Measure: Number of participants
Time frame
From first treatment to the end of treatment at 18 weeks3
Electrocardiogram (ECG) QT Interval Prolongation
Number of participants with QT interval prolongation (QTc \> 450 ms for males, \> 470 ms for females) on 12-lead ECG. • Unit of Measure: ECG QT interval
Time frame
From first treatment to the end of treatment at 18 weeksSecondary outcomes
1
Pharmacokinetic Outcome Measures
Peak Plasma Concentration: Cmax
Time frame
From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)2
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Time frame
From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)3
Pharmacokinetic Outcome Measures
Tmax (Time to Maximum Concentration)
Time frame
From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)4
Pharmacokinetic Outcome Measures
t1/2 (Elimination Half-Life)
Time frame
From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)Sponsors and contacts
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Source ClinicalTrials.gov