NCT06046066 A Phase 1 Study of NM6603 in Advanced Solid Tumors
| NCT ID | NCT06046066 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | NucMito Pharmaceuticals Co. Ltd. |
| Condition | Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-08-31 |
| Primary Completion | 2025-10-31 |
Trial Parameters
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Brief Summary
This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Have a histologically or cytologically confirmed diagnosis of advanced solid tumor; 2. Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy; 3. Have objective (assessable through clinical signs, symptoms, and/or laboratory findings) and radiologically-confirmed progression of disease at Screening; 4. Patients must have measurable disease based on RECIST v1.1; 5. ≥ 18 years of age; 6. Patients must exhibit a/an ECOG performance status of 0-2; 7. Have a life expectancy of at least 12 weeks (in the opinion of the investigator); 8. Have adequate bone marrow reserve: 1. Absolute neutrophil count ≥1.5×109 cell/L; 2. Platelet count ≥100×109 cell/L; 3. Hemoglobin at least ≥9.0 g/dL 9. Have adequate liver function: 1. Total serum bilirubin ≤ 1.5× upper limit of normal (ULN); 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN or ≤5.0× ULN in case of documented hepatic
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