Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients Wit… (NCT06944457) | Clinical Trial Compass
RecruitingPhase 1
Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor
South Korea24 participantsStarted 2024-12-10
Plain-language summary
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
Who can participate
Age range19 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Patients with at least one measurable or unmeasurable but assessable lesion in accordance with Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1
✓. In screening and C1D1, subjects with appropriate hematologic, kidney, and liver function confirmed by the following laboratory test (one more laboratory test is permitted during the screening period)
✓. white blood cell (WBC) ≥ 3,500/mm3
✓. absolute neutrophil count (ANC) ≥ 1,500/mm3 (without CSF administration within 2 weeks prior to C1D1)
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
What they're measuring
1
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) Determination
Timeframe: From first treatment to the end of treatment at 18 weeks
2
Incidence of Treatment-Related Adverse Events
Timeframe: From first treatment to the end of treatment at 18 weeks
3
Electrocardiogram (ECG) QT Interval Prolongation
Timeframe: From first treatment to the end of treatment at 18 weeks
✕. 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
✕. 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\* \[\* Effective Contraception\]
✕. Subjects who have a history of allergies to doxorubicin or the excipient of MPD-1 or is suspicious of allergy