A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShengke Pharmaceuticals (Jiangsu) Limited, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be at least 18 years of age and < 80 years old.
Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures, and can communicated with investigators and are willing to comply with the protocol.
Has histologically or cytologically confirmed relapsed and/or refractory acute myelocytic leukemia(AML) or non-Hodgkin's lymphoma(NHL) with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with ETH-155008 may be beneficial. In addition, the following disease-specific criteria outlined below must be met.
For all indolent NHL (Follicular Lymphoma[FL], Marginal Zone Lymphoma[MZL] and Waldenström Macroglobulinemia[WM]), 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. For chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), 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.
Disqualifiers
Acute promyelocytic leukemia, acute mixed phenotypic leukemia, acute myeloid leukemia with Philadelphia chromosome (Ph chromosome) positive.
AML with myeloid sarcoma.
The central nervous system (CNS) is known to be involved.
Previous solid organ transplantation.
Trial design
Design model
Single group
Treatments tested in this trial
ETH-155008
DrugETH-155008 is an orally bioavailable, potent Pim-3 and CDK4/6 dual kinase inhibitor. Dosage form: 10mg, 20 mg and 40 mg, tablets. ETH-155008 tablets should be taken while fasting, either 1 hour before or 2 hours after a meal.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ETH-155008Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events
Determine the safety of ETH-155008 in subjects with R/R AML and NHL
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Dose Limiting Toxicity (DLTs)
Incidence of DLTs in the first treatment cycle of ETH-155008
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
The RP2D(s) or the MTD of ETH-155008 in subjects with R/R AML and NHL
The RP2D is the maximum tolerated dose (MTD) or less.
Time frame
At the end of Cycle 1 (each cycle is 28 days)Secondary outcomes
1
PK parameter of ETH-155008: Cmax
Maximum Concentration (Cmax) of ETH-155008
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
PK parameter of ETH-155008: Tmax
Time of First Occurrence of Cmax for ETH-155008
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
PK parameter of ETH-155008: AUC
area under the curve (AUC)
Time frame
At the end of Cycle 1 (each cycle is 28 days)4
Disease evaluation of efficacy of ETH-155008: ORR
objective response rate(ORR)
Time frame
12 months post first dosingSponsors and contacts
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Source ClinicalTrials.gov