Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor

NCT06944457 | Recruiting Phase 1 DMC

• 1 other identifier: MPD-1_P1_01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cancer; Solid Tumor Cancer; Biomarkers

Keywords

PTEN Loss; KRAS mutation

Outcome Measures

Primary Outcomes (3)

• 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

  From first treatment to the end of treatment at 18 weeks

• 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

  From first treatment to the end of treatment at 18 weeks

• 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

  From first treatment to the end of treatment at 18 weeks

Secondary Outcomes (5)

• Pharmacokinetic Outcome Measures

  From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)

• Pharmacokinetic Outcome Measures

  From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)

• Pharmacokinetic Outcome Measures

  From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)

• Pharmacokinetic Outcome Measures

  From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)

• Pharmacokinetic Outcome Measures

  From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8)

Study Arms (1)

MPD-1 treatment

EXPERIMENTAL

Drug: MPD-1

Interventions

MPD-1 DRUG

It is a prodrug that uses Doxorubicin to target KRAS mutant/ PTEN loss advanced cancer.

MPD-1 treatment

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
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• white blood cell (WBC) ≥ 3,500/mm3
• absolute neutrophil count (ANC) ≥ 1,500/mm3 (without CSF administration within 2 weeks prior to C1D1)
• platelets ≥ 100,000/mm3 (without transfusion within 2 weeks prior to C1D1)
• hemoglobin (Hb) ≥ 10 g/dL (without transfusion within 2 weeks prior to C1D1)
• total bilirubin ≤ 1.5 times the normal upper limit (However, in case of Gilbert syndrome, this patient can participate in this clinical trial regardless of the results of total bilirubin
• aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the normal upper limit (five times of the normal upper limit in case of liver metastasis)
• albumin ≥ 2.5 g/dL
• serum creatinine ≤ 1.5 times the normal upper limit

You may not qualify if:

• 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
• \- Clinically significant symptomatic or uncontrolled central nervous system metastasis (but can participate in this clinical trial if systemic corticosteroids have not been administered for more than 2 weeks prior to C1D1 and the condition is stable)
• 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.)
• History of thrombosis (e.g., thrombophlebitis, etc.)
• Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
• Clinically significant ascites
• Subjects who are infected with or carrying hepatitis B virus (HBV) or hepatitis C virus (HCV)\* \* When screening, serology tests show that any one of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis B core antibody-immunoglobulin M (HBcAb-IgM), and hepatitis C virus antibody (HCV Ab) (However, if the HCV Ab test result is suspected to be false positive or positive due to past infection, HCV RNA test may be performed at each institution under the judgement of investigator and the HCV Ab and RNA test results are integrated to decide whether HCV is infected.)
• The following medical history is identified during screening
• Chickenpox or varicella zoster infection within 12 weeks prior to C1D1
• Uncontrolled active infectious diseases including known human immunodeficiency virus (HIV) positives
• 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

Sponsors & Collaborators

• Pharosgen Co.,Ltd: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sangyoon Kim, MD, PhD

  Pharosgen Co.,Ltd

  STUDY DIRECTOR

Central Study Contacts

Geon Tae Park, Bachelor's degree

CONTACT

82-10-2704-8955; gtpark@pharosgen.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: conventional 3+3 design with 4 arms (cohorts) to find RP2D.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: April 25, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

KR (1)