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A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 alone and in Combination with Cytarabine (Ara-C) in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome with Wild-Type TP53
The purpose of this study is to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 in participants with acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53.
Primary Objectives: - Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine (Ara-C) in adult patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) with wild-type (WT) TP53 who are relapsed/refractory to or intolerant of standard therapy, or for whom no standard therapy exists. - Determine the dose limiting toxicities (DLT) and the maximum tolerated dose (MTD) of ALRN-6924 alone and in combination with cytarabine in adult patients with AML or advanced MDS. Secondary Objectives: - Describe the pharmacokinetics (PK) of ALRN-6924 and its metabolite and of cytarabine in blood following single and multiple intravenous (IV) infusions. - Evaluate potential clinical activity of ALRN-6924 alone and in combination with cytarabine in patients with AML or advanced MDS with WT TP53. - Investigate the immunogenicity of ALRN-6924. Exploratory Objectives: - Assess the relationship between clinical outcome and potential biomarkers such as pre-treatment p53,MDM2 and MDMX status in AML and MDS cells in bone marrow and/or peripheral blood. - Assess the effect of ALRN-6924 treatment, alone and in combination with cytarabine, on potential PD biomarkers (e.g., p53, p21, caspase, apoptosis) and TP53 mutation status in AML and MDS cells in bone marrow and/or peripheral blood.