Actively Recruiting
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
Led by Shanghai Yuyao Biotech Co., Ltd. · Updated on 2024-01-31
96
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent and be able to follow all study procedures.
- Aged between 18 and 80 years, male or female.
- Patients with advanced solid tumors or relapsed/refractory hematologic malignancies who have failed or cannot tolerate standard treatments.
- For advanced solid tumors in the dose-escalation phase, at least one tumor lesion evaluable by RECIST v1.1.
- For dose-expansion phase, measurable tumor lesions per RECIST v1.1, with specific criteria for previously irradiated tumors.
- Enrollment in dose-expansion phase limited to advanced solid tumors sensitive to STAT3 therapy, peripheral T-cell lymphoma with STAT3 mutation refractory or relapsed after therapy, and relapsed/refractory acute myeloid leukemia sensitive to STAT3 therapy excluding certain subtypes.
- ECOG performance status of 1 or less.
- For advanced primary liver cancer, Child-Pugh liver function grade A or better grade B (7 or less).
- Adequate bone marrow, liver, kidney, and coagulation function according to specified laboratory thresholds.
- Agreed to provide tumor tissue samples in dose-expansion phase.
- Expected survival of at least 3 months.
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during and 30 days after treatment.
You will not qualify if you...
- Previous adverse reactions from anti-cancer therapy have not recovered to CTCAE grade 1 or less, except for certain non-safety-risk toxicities.
- Symptomatic central nervous system metastases or CNS involvement for AML patients.
- Recent chemotherapy, radiation, biological, endocrine, or immune therapies within 4 weeks before first dose, with some exceptions.
- Use of other investigational drugs within 4 weeks before first dose.
- Prior use of STAT3 inhibitors for anti-tumor treatment.
- Major organ surgery within 4 weeks before first dose or planned elective surgery during the trial.
- Uncontrolled malignant pleural, ascites, or pericardial effusions.
- Inability to swallow oral medication or conditions affecting gastrointestinal absorption.
- Use of strong CYP3A4 inducers or inhibitors within 1 week before first dose or planned during study.
- Active gastrointestinal diseases or bleeding conditions.
- Recent thromboembolic events within 12 months.
- Significant cardiovascular disease including recent heart attack, severe angina, heart failure, low ejection fraction, or prolonged QTc.
- Active or previous autoimmune diseases with potential recurrence, excluding stable thyroid disease and type I diabetes.
- Prior immunotherapy with severe immune-related adverse events.
- Significant electrolyte abnormalities.
- Active infections requiring treatment or fever above 38.5°C before dosing.
- Active tuberculosis, HIV infection, or active hepatitis B or C infections.
- Recent hematopoietic stem cell transplant or ongoing immunosuppressive therapy or graft-versus-host disease requiring drug control.
- Pregnant or breastfeeding women.
- Men wishing to father children.
- Known alcohol or drug dependence.
- Inability to comply with study procedures.
- Any other clinically significant disease or abnormality that may affect safety or study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Ye Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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