Actively Recruiting
A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients
Led by Shengke Pharmaceuticals (Jiangsu) Limited, China · Updated on 2024-05-08
60
Participants Needed
2
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Trial is an open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with AML and NHL who previously received standard treatment or are ineligible for standard treatment options.
CONDITIONS
Official 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 between 18 and 79 years old.
- Sign informed consent and be willing to comply with study procedures.
- Have confirmed relapsed or refractory AML or NHL with no standard treatment options or are not candidates for standard therapy.
- For indolent NHL, have had at least two prior systemic treatments including anti-CD20 antibody therapy.
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, have had at least two prior systemic therapies including BTK or BCL-2 inhibitors.
- For mantle cell lymphoma, have had two prior systemic therapies including anti-CD20 and BTK inhibitors.
- For aggressive B-NHL, have failed or relapsed after standard therapies or are unable to tolerate intensive therapies.
- For T-NHL, have been treated with standard systemic drugs without remission or recurrence.
- AML diagnosis per WHO 2016, relapsed or refractory with no available or tolerated standard treatment.
- Measurable lesions meeting specified size criteria for NHL.
- ECOG performance status 0 or 1 for dose escalation; 0 to 2 for dose expansion.
- Hematology and blood biochemistry within specified ranges.
- Life expectancy of at least 3 months.
- For women of childbearing potential, negative pregnancy test and agreement to use effective contraception.
- Agreement to avoid sperm or egg donation during and for 3 months after study.
- Willingness and ability to adhere to study requirements.
You will not qualify if you...
- Acute promyelocytic leukemia, acute mixed phenotypic leukemia, or Philadelphia chromosome-positive AML.
- AML with myeloid sarcoma.
- Known involvement of the central nervous system.
- Previous solid organ transplant.
- Previous allogeneic hematopoietic stem cell transplant.
- Autologous stem cell transplant within 3 months prior to study drug.
- Active autoimmune disease requiring systemic immunosuppressive treatment in past 2 years.
- Unresolved toxicities from prior anti-cancer therapies greater than Grade 1, except alopecia and peripheral neuropathy.
- Past or current malignancies other than specified exceptions.
- Prior treatment with CDK4/6 or Pim inhibitors.
- Allergies or intolerance to ETH-155008 or its components.
- Recent chemotherapy, targeted therapy, radiotherapy, or investigational treatments within specified time frames.
- Prior CAR-T cell therapy within 12 weeks.
- High-dose corticosteroid use beyond allowed limits.
- Significant cardiovascular disease within 6 months before study.
- Clinically significant pulmonary compromise requiring oxygen.
- Conditions affecting swallowing or gastrointestinal function.
- Active infections requiring treatment or chronic hepatitis B, C, or HIV infection.
- Positive syphilis antibody.
- Major surgery within 28 days prior to study drug.
- Serious medical or psychiatric conditions impairing study participation.
- Use of prohibited medications or CYP3A4 substrates/inducers/inhibitors within specified periods.
- Pregnant or breastfeeding women.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
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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
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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