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

NCT ID: NCT06944457

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MPD-1 treatment

Group Type: EXPERIMENTAL

MPD-1

Intervention Type: DRUG

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

Interventions

MPD-1

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 19 to 75 years of age

2. 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.

3. KRAS mutation or PTEN loss is confirmed in tumor tissues prior to screening, and there is a documented record of this

4. Patients without the history of administration of anthracycline drugs and/or anthracene

5. Patients with at least one measurable or unmeasurable but assessable lesion in accordance with Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1

6. 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)

<!-- -->

1. white blood cell (WBC) ≥ 3,500/mm3

2. absolute neutrophil count (ANC) ≥ 1,500/mm3 (without CSF administration within 2 weeks prior to C1D1)

3. platelets ≥ 100,000/mm3 (without transfusion within 2 weeks prior to C1D1)

4. hemoglobin (Hb) ≥ 10 g/dL (without transfusion within 2 weeks prior to C1D1)

5. 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

6. 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)

7. albumin ≥ 2.5 g/dL

8. serum creatinine ≤ 1.5 times the normal upper limit

Exclusion Criteria

1. 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

2. Participation in other interventional clinical trials (administration of investigational new drugs or use of investigational medical devices) within 4 weeks prior to C1D1

3. 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.)

4. 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

5. 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

6. Pregnant women, nursing mothers, and fertile women with plan for pregnancy

7. 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.

8. Subjects who have a history of allergies to doxorubicin or the excipient of MPD-1 or is suspicious of allergy

9. 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)

10. 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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharosgen Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangyoon Kim, MD, PhD

Role: STUDY_DIRECTOR

Pharosgen Co.,Ltd

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Geon Tae Park, Bachelor's degree

Role: CONTACT

gtpark@pharosgen.co.kr

82-10-2704-8955

Facility Contacts

Kyupyo Kim, MD, PhD

Role: primary

kkp1122@amc.seoul.kr

82-10-9949-2284

Other Identifiers

MPD-1_P1_01

Identifier Type: -

Identifier Source: org_study_id