NCT06944457 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of MPD-1 in Patients With Advanced Solid Tumor
| NCT ID | NCT06944457 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pharosgen Co.,Ltd |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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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
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)
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