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CancerPhase 1NCT06944457

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

A Phase 1 study testing MPD-1 in people with Cancer and Solid Tumor Cancer, run by Pharosgen Co.,Ltd at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Cancer, Solid Tumor Cancer, Biomarkers
What is being tested?
MPD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
10 Dec 2024to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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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
  • INR ≤ 1.5 times the normal upper limit 7) Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 8) Patients with an expected survival period of more than 12 weeks 9) Patients who have recovered from previous therapy-related adverse event to Common Terminology Criterion for Adverse Events (CTCAE) version 5.0 grade 1 or below or to C1D1 levels (However, sHair loss (regardless of grade), subjects can be enrolled if they have with hair loss (regardless of grade) or peripheral neuropathy below grade 2 or laboratory test results show that they do not meet the exclusion criteria) can be enrolled.) 10) Patients, who after understanding all the relevant information of this clinical trial, decides to participate, and voluntarily signed a written agreement.

Who cannot join

  • 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.)
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  • 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
  • G-CSF administration to correct absolute neutrophil count (ANC) levels within 2 weeks prior to C1D1
  • -- Transfusion of packed red cells or platelets to correct platelets or hemoglobin levels within 2 weeks prior to C1D1
  • Trastuzumab within 28 weeks prior to 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]
  • Hormone contraception (oral contraceptives, subcutaneous implants, etc.)
  • Intrauterine device (IUD) or implantation of an intrauterine system (IUS) ③ Infertility procedures or surgeries (vasectomy, bilateral oviduct ligation/excision, hysterectomy, etc.)
  • Double contraception (concurrent use of contraceptive methods from ①~③ and condoms for men or women) ⑤ Absolute abstinence: Based on investigator's judgment, thorough abstinence from sex is approved if the subject's age, occupation, lifestyle, or sexual orientation guarantee contraception. However, periodic abstinence (menstrual cycle, mucus method, symptomatic body temperature method, etc.), resection, and withdrawal method (coitus interruptus) are not recognized as appropriate contraception methods.
  • Subjects who have a history of allergies to doxorubicin or the excipient of MPD-1 or is suspicious of allergy
  • Subjects in a state of prohibiting, limiting, or disrupting the assessments specified in the clinical trial (e.g., a history of alcohol or drug abuse within two years prior to C1D1)
  • Subjects considered as unsuitable for participation in the clinical trial by the investigator (e.g., if the patient's health is unsuitable or participation in this clinical trial is not the best treatment for the patient)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Geon Tae Park, Bachelor's degree contact

82-10-2704-8955

gtpark@pharosgen.co.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, 05505

    Kyupyo Kim, MD, PhD, 82-10-9949-2284, kkp1122@amc.seoul.kr

    Kyupyo Kim, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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

Being tested
MPD-1
Keywords
PTEN Loss, KRAS mutation
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPD-1Drug

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

Study groups in NCT06944457
Study groupRoleWhat they receive
MPD-1 treatmentExperimentalNot described
Receives: Drug: MPD-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From first treatment to the end of treatment at 18 weeks

  2. 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

    Measured: From first treatment to the end of treatment at 18 weeks

  3. 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

    Measured: From first treatment to the end of treatment at 18 weeks

Secondary outcomes (5)

  1. Pharmacokinetic Outcome Measures

    Peak Plasma Concentration: Cmax

    Measured: 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)

    Measured: 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)

    Measured: 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)

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

  5. Pharmacokinetic Outcome Measures

    CL (Clearance)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start10 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
conventional 3+3 design with 4 arms (cohorts) to find RP2D.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944457
Sponsor's protocol ID
MPD-1_P1_01
Status last verified
Apr 2025
First submitted
18 Nov 2024
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MPD-1 in people with Cancer and Solid Tumor Cancer, run by Pharosgen Co.,Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Geon Tae Park, Bachelor's degree (82-10-2704-8955, gtpark@pharosgen.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) Determination (time frame: From first treatment to the end of treatment at 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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