OncoMatch/Clinical Trials/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
Is NCT06225856 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies YY201 for advanced solid tumor.
Treatment: YY201 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: STAT3 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — relapsed/refractory
relapsed or refractory hematologic malignancies
Cannot have received: STAT3 inhibitor
Previously received STAT3 inhibitor for anti-tumor treatment
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin ≥85g/L (solid tumors); For PTCL: hemoglobin ≥80g/L, neutrophils ≥1.0×10^9/L, platelets ≥75×10^9/L; For AML: WBC ≤25×10^9/L
Kidney function
Creatinine ≤1.5×ULN; Creatinine clearance (Ccr) ≥50ml/min (if creatinine >1.5×ULN)
Liver function
Total bilirubin (TBIL) ≤1.5×ULN; ALT ≤3×ULN (≤5×ULN if liver involvement); AST ≤3×ULN (≤5×ULN if liver involvement); For advanced primary liver cancer: Child-Pugh grade A or B (≤7)
Cardiac function
LVEF ≥50%; No NYHA grade ≥2 heart failure; No acute MI, unstable angina, or CABG within 6 months; No significant QTc prolongation (>470ms women, >450ms men)
adequate bone marrow, liver, and kidney function is required... For advanced primary liver cancer should meet the Child-Pugh liver function grading: grade A and better grade B (≤7)... LVEF <50%; NYHA grade ≥2; acute MI, unstable angina, or CABG within 6 months; significant QTc prolongation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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