NCT06235437 Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASD141
| NCT ID | NCT06235437 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ascendo Biotechnology Co., Ltd. |
| Condition | Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a Phase I study designed to evaluate if ASD141 is safe, tolerable, and efficacious in participants with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * Subject has voluntarily agreed to participate by giving written informed consent. * Male or female ≥ 18 years of age on the day of signing informed consent. * Has a histologically or cytologically confirmed metastatic solid tumor for which there is no available therapy that is expected to convey clinical benefit. * Has at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Subjects must have a performance status of ≤ 1 on the ECOG performance scale. * Subjects must have adequate organ function as indicated by the following laboratory values. Hematological Neutrophil Count (ANC) ≥ 1,500 /µL (mm3) Platelets ≥ 100,000 /µL (mm3) Hemoglobin ≥ 9 g/dL Renal estimated GFR (non-indexed)\* ≥ 50 mL/min Hepatic Serum total bilirubin ≤ 1.5X ULN OR Direct bilirubin ≤ 1.5X ULN for subjects with total bilirubin levels \> 1.5 ULN; ≤ 3X ULN for subjects with hepatoma or Gilbert's disease AST and ALT ≤ 2.5X ULN OR ≤ 5X ULN for subjects with a