NCT06225856 An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies
| NCT ID | NCT06225856 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Yuyao Biotech Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-10-26 |
| Primary Completion | 2026-12-30 |
Trial Parameters
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Brief Summary
This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
Eligibility Criteria
Inclusion Criteria: * 1.Patients fully understand and sign ICF, voluntarily participate in the study, and able to follow and complete all study procedures. * 2.Aged 18-80 years (including upper and lower limits), male or female. * 3\. The standard treatment failure (disease progression after treatment or treatment side effects not tolerance), or top treatment, or shall not apply to the current standard treatment for patients with: * Surgical excision is confirmed by histology or cytology can't or metastatic patients with advanced solid tumor; * Patients with relapsed or refractory hematologic malignancies * 4\. For patients with advanced solid tumors (dose-escalation phase), at least one tumor lesion that could be evaluated according to RECIST, version 1.1; (Dose-expansion phase) At least one measurable tumor lesion according to RECIST, version 1.1 (a tumor that is located in the previously irradiated area or another locoregional treatment site and is generally not considered a measura