OncoMatch/Clinical Trials/NCT05758610
A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients
Is NCT05758610 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies ETH-155008 for nhl, adult.
Treatment: ETH-155008 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
previously treated with at least 2 prior lines of systemic therapy with at least 1 line being an anti-cluster of differentiation antigen 20(anti-CD20) antibody-containing combination regimen
Must have received: systemic therapy
prior treatment with at least 2 lines of systemic therapy, including Bruton's tyrosine kinase(BTK) inhibitors or B-cell lymphoma-2(BCL-2) inhibitors, is required
Must have received: systemic therapy
prior treatment with at least 2 lines of systemic therapy (including a combination regimen of anti-CD20 antibodies and BTK inhibitors)
Must have received: standard second-line therapy or standard first-line therapy
patients who can tolerate intensive therapy or autologous hematopoietic stem cell transplantation are required to have received standard second-line therapy in the past but have failed or relapsed. If patients cannot tolerate intensive therapy or autologous hematopoietic stem cell transplantation, they must have received standard first-line therapy in the past, but therapy failed or relapsed
Must have received: systemic standard dose of drugs
adequately treated with a systemic standard dose of drugs in the past without remission or recurrence
Cannot have received: CDK4/6 inhibitor
Prior treatment with a cyclin dependent kinase 4 and 6(CDK4/6) ... inhibitor
Cannot have received: Pim inhibitor
Prior treatment with a ... Pim inhibitor
Cannot have received: allogeneic hematopoietic stem cell transplantation
Previously received allogeneic hematopoietic stem cell transplantation
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: within 3 months prior to initial administration of ETH-155008
The patient received autologous hematopoietic stem cell transplantation (HSCT) within 3 months prior to initial administration of ETH-155008
Cannot have received: chemotherapy or targeted therapy
Exception: within 2 weeks (or five half-lives, which is the longer) prior to first dosing treatment
Prior chemotherapy or targeted therapy within 2 weeks(Or five half-lives, which is the longer) prior to first dosing treatment
Cannot have received: investigational anticancer agent or radiotherapy (including investigational vaccines)
Exception: within 4 weeks before the first administration of ETH-155008
treatment with an investigational anticancer agent or radiotherapy (including investigational vaccines) within 4 weeks before the first administration of ETH-155008
Cannot have received: CAR-T cell therapy
Exception: within 12 weeks before the first administration of ETH-155008
Prior chimeric antigen receptor T-Cell(CAR-T) immunotherapy within 12 weeks before the first administration of ETH-155008
Lab requirements
Blood counts
For NHL: Hemoglobin ≥80g/L (≥60g/L if bone marrow invasion); Platelet count ≥75×10^9/L (≥50×10^9/L if bone marrow invasion); ANC ≥1.0×10^9/L (≥0.75×10^9/L if bone marrow invasion). For AML: WBC <25×10^9/L before first administration
Kidney function
Creatinine clearance rate(CCr)≥45 ml/min (Cockcroft-Gault formula)
Liver function
AST, ALT ≤2.5×ULN (≤5×ULN if primary liver invasion); TBIL ≤1.5×ULN (≤3×ULN if primary liver invasion)
Cardiac function
QTcF female >470ms, male >450ms excluded; no recent MI, unstable angina, significant arrhythmias, uncontrolled hypertension, stroke/TIA, VTE within 1 month, CHF NYHA III-IV, pericarditis, myocarditis, endocarditis
Blood biochemical test results must be within the following range: AST, ALT ≤2.5×ULN (≤5×ULN if primary liver invasion); TBIL ≤1.5×ULN (≤3×ULN if primary liver invasion); Creatinine clearance rate(CCr)≥45 ml/min (Cockcroft-Gault formula); Prothrombin time(PT) and activated partial thromboplastin time(aPTT) ≤1.5×ULN. For NHL, hematology laboratory parameters ... For AML, ... WBC <25×10^9/L before first administration. Cardiac: see exclusion criteria 15.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05758610 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, Pim inhibitor, allogeneic hematopoietic stem cell transplantation disqualifies patients from 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.
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