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A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tuspetinib (HM43239) in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Full description
This is a Phase 1/2, open-label, multi-center study to assess the efficacy, safety, tolerability, pharmacokinetics, including recommended phase 2 dose (RP2D) of tuspetinib (HM43239) monotherapy in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML). This study will also evaluate the safety, tolerability, and PK parameters of tuspetinib (HM43239) in combination with venetoclax when administered in patients with R/R AML
Enrollment
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Inclusion criteria
Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2016) and fulfills one of the following:
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patient's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). (upon discussion with the Medical Monitor, shorter than stated washout period may be considered provided that the patient has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies)
Patient must meet the following criteria as indicated on the clinical laboratory tests
Patient is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)
Female patient must be either:
Of non-child bearing potential
Or, if of childbearing potential,
Female patient must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration
Female patient must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
Male patient and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.
Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
Patient agrees not to participate in another interventional study while on treatment
Exclusion criteria
Patients must not enter the study if any of the following exclusion criteria are fulfilled.
Patient was diagnosed as acute promyelocytic leukemia (APL)
Patient has BCR-ABL-positive leukemia
Patient has an active malignancy other than AML, or Myelodysplastic Syndrome (MDS).
Patient has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)
Patient has had hematopoietic stem cell transplant (HSCT) and meets any of the following:
Patient has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.
Patient has disseminated intravascular coagulation abnormality (DIC).
Patient has had major surgery within 4 weeks prior to the first study dose.
Patient has had radiation therapy within 4 weeks prior to the first study dose.
Patient has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patient with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
Any of the following cardiac abnormalities of history
Patient is known to have active infection including any identified active COVID-19 infection.
Patient is known to have human immunodeficiency virus infection.
Patient has known active hepatitis B or C, or other active hepatic disorder.
Patient has any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.
Patient has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor.
Primary purpose
Allocation
Interventional model
Masking
218 participants in 4 patient groups
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Central trial contact
Rafael Bejar, MD, PhD
Data sourced from clinicaltrials.gov
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