A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM43239 in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Leucemia mieloide aguda, Linfoma, Leucemia
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Gala Vega Achabal
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Gabriela Rodriguez-Macias
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Carmen Martinez Chamorro
FECHA DE APERTURA
Junio, 2023
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Patient is ¿ 18 years of age (or country's legal age of majority if the legal age is > 18 years) at the time of obtaining informed consent.
Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization criteria (2016) and fulfills one of the following: a) Refractory to at least 1 cycle of prior therapy. b) Relapsed after achieving remission with the most recent prior therapy.
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 least 4 weeks for biologic cellular immunotherapies, or at least 5 half-lives for prior experimental agents or 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: a) Serum aspartate aminotransferase and alanine aminotransferase ¿ 2.5× institutional upper limit of normal (ULN). b) Total serum bilirubin ¿ 1.5× institutional ULN. c) Serum creatinine ¿ 1.5× institutional ULN or an estimated glomerular filtration rate of > 45 mL/min as calculated by the Modification of Diet in Renal Disease equation.
Patient is defined as having morphologically documented primary or secondary AML by the World Health Organization criteria (2016) and fulfills one of the following: a) Refractory to at least 1 cycle of prior therapy. b) Relapsed after achieving remission with the most recent prior therapy.
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 least 4 weeks for biologic cellular immunotherapies, or at least 5 half-lives for prior experimental agents or 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: a) Serum aspartate aminotransferase and alanine aminotransferase ¿ 2.5× institutional upper limit of normal (ULN). b) Total serum bilirubin ¿ 1.5× institutional ULN. c) Serum creatinine ¿ 1.5× institutional ULN or an estimated glomerular filtration rate of > 45 mL/min as calculated by the Modification of Diet in Renal Disease equation.
CRITERIOS DE EXCLUSIÓN
Patient was diagnosed as acute promyelocytic leukemia.
Patient has known BCR-ABL-positive leukemia.
Patient has an active malignancy requiring therapy other than AML or myelodysplastic syndrome.
Patient has persistent non-hematological toxicities of ¿ Grade 2 (Common Terminology Criteria for Adverse Events v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
Patient has had HSCT and meets any of the following: a) Has undergone HSCT within the 2-month period prior to the first study dose b) Has clinically significant graft-versus-host-disease requiring treatment c) Has ¿ Grade 2 persistent non-hematological toxicity related to the transplant d) Has a donor lymphocytes infusion (DLI) ¿ 30 days prior to the first study dose or during the first 2 cycles of treatment in the study.
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 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 a tyrosine kinase inhibitor.
Patient has known BCR-ABL-positive leukemia.
Patient has an active malignancy requiring therapy other than AML or myelodysplastic syndrome.
Patient has persistent non-hematological toxicities of ¿ Grade 2 (Common Terminology Criteria for Adverse Events v4.03), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
Patient has had HSCT and meets any of the following: a) Has undergone HSCT within the 2-month period prior to the first study dose b) Has clinically significant graft-versus-host-disease requiring treatment c) Has ¿ Grade 2 persistent non-hematological toxicity related to the transplant d) Has a donor lymphocytes infusion (DLI) ¿ 30 days prior to the first study dose or during the first 2 cycles of treatment in the study.
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 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 a tyrosine kinase inhibitor.
DESCRIPCIÓN
- To determine the recommended phase 2 dose based on safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) consideration. - To evaluate the safety, tolerability, and PK parameters of HM43239 when administered in patients with relapsed or treatment-refractory (R/R) AML. - To evaluate the safety, tolerability, and PK parameters of HM43239 in combination with venetoclax when administered in patients with R/R AML.
PALABRAS CLAVE
acute myeloid leukemia, aml, leukemia, ph + acute lymphoblastic leukemia, refractory aml, relapsed aml
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