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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, and preliminary anti-tumor effects of YY201 in patients with advanced solid tumors and blood cancers who have relapsed or are refractory to standard treatments. This phase I, open-label, multicenter study focuses on patients who cannot tolerate or have failed standard care, aiming to find a suitable dose and explore how the drug works in these conditions. The study has two phases: a dose escalation phase to determine the maximum tolerated dose or recommended dose for further studies, and a dose expansion phase to evaluate the anti-tumor activity of YY201. Participants will receive YY201 orally under fasting conditions, either as a single dose or once daily in multiple doses. Specific patient groups in the expansion phase include those with advanced solid tumors sensitive to STAT3 therapy, peripheral T-cell lymphoma with STAT3 mutation, and relapsed/refractory acute myeloid leukemia. Participants will undergo regular assessments including safety monitoring, laboratory tests, and tumor evaluations to measure responses and side effects. Primary outcomes include dose limiting toxicities, maximum tolerated dose, and treatment-emergent adverse events during up to 24 months. Secondary measures track drug concentration in blood, response duration, time to response, and overall survival. The study requires participants to be aged 18 to 80 years and able to comply with all procedures throughout the study period.
CONDITIONS
Brief 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 fully understand and voluntarily sign informed consent and be able to complete all study procedures.
- Aged 18 to 80 years, male or female.
- Have advanced solid tumors or relapsed/refractory hematological malignancies with failure or intolerance to standard treatment.
- For advanced solid tumors, have at least one tumor lesion evaluable by RECIST version 1.1.
- For dose expansion, must have specific tumor types sensitive to STAT3 therapy or meet defined criteria for lymphoma or leukemia.
- ECOG performance status of 0 or 1.
- Advanced primary liver cancer patients must have Child-Pugh grade A or B (≤7).
- Adequate bone marrow, liver, kidney, and coagulation function as defined by laboratory tests.
- Agree 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 and agree to use effective birth control during and 30 days after the study.
You will not qualify if you...
- Previous adverse reactions from anti-cancer therapy not recovered to grade 1 or better (except certain non-safety risks).
- Symptomatic brain metastases or CNS involvement in AML patients.
- Recent chemotherapy, radiation, biological, endocrine, or immune therapy within defined timeframes.
- Prior use of STAT3 inhibitors.
- Major surgery within 4 weeks or planned elective surgery during the trial.
- Uncontrolled pleural, ascites, or pericardial effusion.
- Inability to swallow or absorb oral medication properly.
- Use of strong CYP3A4 inducers or inhibitors within 1 week before dosing.
- Active gastrointestinal diseases or bleeding-risk conditions.
- Thromboembolic events within 12 months.
- Significant cardiovascular disease or abnormal heart function.
- Active or unstable autoimmune diseases (except stable thyroid disease and type I diabetes).
- Prior severe immune therapy-related adverse events.
- Significant electrolyte abnormalities.
- Active infection or fever at screening.
- Active tuberculosis, HIV infection, or active hepatitis B or C infection.
- Recent hematopoietic stem cell transplant or graft-versus-host disease requiring treatment.
- Pregnant or breastfeeding women.
- Men with fertility needs.
- Known alcohol or drug dependence.
- Any other condition that may interfere with study participation or safety as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive oral doses of YY201 under fasting conditions to evaluate safety, pharmacokinetics, and preliminary efficacy.
Multiple visits during treatment including dose escalation and dose expansion phases
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Ye Guo
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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