Biomarkers, Cancer, Solid Tumor Cancer
Conditions
Keywords
PTEN Loss, KRAS mutation
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
Interventions
DRUGMPD-1
It is a prodrug that uses Doxorubicin to target KRAS mutant/ PTEN loss advanced cancer.
Sponsors
Pharosgen Co.,Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
conventional 3+3 design with 4 arms (cohorts) to find RP2D.
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) Determination | From first treatment to the end of treatment at 18 weeks | 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 |
| Incidence of Treatment-Related Adverse Events | From first treatment to the end of treatment at 18 weeks | Number of participants experiencing treatment-related adverse events, as assessed by CTCAE v5.0. • Unit of Measure: Number of participants |
| Electrocardiogram (ECG) QT Interval Prolongation | From first treatment to the end of treatment at 18 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Outcome Measures | From first treatment (Cycle 1, Day 1) to one week after the first treatment (Cycle 1, Day 8) | Peak Plasma Concentration: Cmax |
Countries
South Korea
Contacts
Primary ContactGeon Tae Park, Bachelor's degree
Outcome results
None listed