Actively Recruiting
A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ETH-155008 Tablets in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Non-Hodgkin's Lymphoma
Led by Shengke Pharmaceuticals (Jiangsu) Limited, China · Updated on 2024-05-08
60
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of ETH-155008 in adults with relapsed or refractory acute myeloid leukemia (AML) and non-Hodgkin's lymphoma (NHL) who have previously received standard treatments or are not eligible for those options. This is a Phase I, open-label, multicenter clinical trial that aims to find the recommended dose or maximum tolerated dose of ETH-155008. The study also explores the drug's impact on specific kinases and its potential anti-tumor activity. The study has two parts: dose escalation and cohort expansion. In dose escalation, participants receive oral ETH-155008 once daily for 28-day cycles, with doses ranging from 20 mg to 100 mg. The safety and dose-limiting toxicities are assessed during the first cycle to identify the maximum tolerated dose. Afterward, more participants are treated at the recommended Phase 2 dose during the cohort expansion phase. Safety is closely monitored by a data review committee throughout the study. Participants will undergo assessments for side effects, drug levels in the body, and disease response over time. Safety is evaluated at the end of each 28-day cycle, focusing on adverse events and dose-limiting toxicities. Researchers also measure how the drug affects specific kinases two months after starting treatment and evaluate disease outcomes such as response rates up to 12 months after the first dose. The study continues until safety and dosing goals are met, with ongoing monitoring for any late-onset toxicities.
CONDITIONS
Brief Title
A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old and younger than 80 years.
- Provide signed informed consent and agree to comply with study procedures.
- Have confirmed relapsed or refractory acute myelocytic leukemia (AML) or non-Hodgkin's lymphoma (NHL) with no available standard therapy or are not candidates for standard treatment.
- For indolent NHL, have received at least 2 prior lines of therapy including anti-CD20 antibody regimen; for CLL/SLL, prior treatment with 2 lines including BTK or BCL-2 inhibitors.
- For mantle cell lymphoma, prior treatment with at least 2 systemic therapies including anti-CD20 and BTK inhibitors.
- For aggressive B-NHL, must have failed or relapsed after standard therapies or be unable to tolerate intensive therapy.
- For T-NHL, previously treated with standard systemic drugs without remission or with recurrence.
- For AML, relapsed or refractory per WHO 2016 classification, no standard or tolerated treatment available.
- Have measurable lesions or disease parameters as per specific lymphoma or leukemia criteria.
- ECOG performance status 0 or 1 for dose escalation, or 0 to 2 for dose expansion.
- Meet specific blood count and biochemical test criteria without recent transfusions or growth factors.
- Life expectancy of at least 3 months.
- Women of childbearing potential must have negative pregnancy test and use effective contraception; men must agree to birth control methods.
- Willing and able to follow study requirements and protocol.
You will not qualify if you...
- Acute promyelocytic leukemia, mixed phenotypic leukemia, or Philadelphia chromosome-positive AML.
- AML with myeloid sarcoma or central nervous system involvement.
- Previous solid organ transplant or allogeneic stem cell transplant.
- Autologous stem cell transplant within 3 months before study drug.
- Active autoimmune disease requiring systemic immunosuppressive treatment within past 2 years.
- Unresolved toxicities from prior cancer therapy except alopecia or peripheral neuropathy.
- Other current or past malignancies unless cured or low risk as specified.
- Prior treatment with CDK4/6 or Pim inhibitors.
- Known allergies or intolerance to ETH-155008 or its ingredients.
- Recent chemotherapy, targeted therapy, radiotherapy, or CAR-T within specified washout periods.
- High dose corticosteroid use beyond allowed limits.
- Significant cardiovascular disease within 6 months prior to study drug.
- Clinically significant pulmonary issues requiring supplemental oxygen.
- Unable to swallow tablets or significant gastrointestinal disorders affecting absorption.
- Active infections requiring treatment, including hepatitis B, hepatitis C, HIV, or syphilis.
- Major surgery or trauma within 28 days prior to study drug.
- Serious medical or psychiatric conditions affecting study participation.
- Use of prohibited medications or CYP3A4 inducers/inhibitors within 1 week prior to treatment.
- Pregnant or breastfeeding women.
- Other conditions judged unsuitable by investigator for participation.
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 - 28-day cycles; repeated until dose escalation completion or cohort expansion end
Participants receive ETH-155008 tablets orally once daily for 28-day cycles to evaluate safety, tolerability, and initial efficacy.
Daily dosing with regular clinic visits during each 28-day cycle
Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
2
Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
James Zhang, Master
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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