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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06225856 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior STAT3 inhibitor disqualifies patients from enrollment.
Does this trial require STAT3?
Yes, STAT3 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify