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Gilteritinib

Tyrosine Kinase Inhibitors

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Iadademstat

Gilteritinib Oral Tablet

Ana Limón, PhD

Sonia Gutiérrez, MSc

Rajneesh Nath, MD

Sharad Khurana, MD, MSc

Sharad Khurana, MD

Sangeetha Venugopal, MD

Guenther Koehne, MD, PhD

Alexander J Ambiender, MD

Amir Fathi, MD

Neil D Palmisiano, MD, MS

Jonathan Feld, MD

Alice Mims, MD

Theodore P Braun, MD PhD

Robert L. Render, M.D.

Stephen Strickland, MD

Konstantinos Sdrimas, MD

Guru SG Murthy, MD

Douglas Faller, PhD

Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.

This is an escalation/expansion, open label, single arm, study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R AML.

This study consists of 2 parts. A dose finding part to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and emerging activity of iadademstat and gilteritinib combination, and to determine the pharmacologically-active dose (i.e., the minimum safe and biologically active dose) of iadademstat in combination with gilteritinib, and an expansion part at the specific dose/s selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study

Number of participants with Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Number of participants with laboratory value abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Number of participants with vital signs abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Number of participants with Routine 12-lead electrocardiogram (ECG )abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Determine the recommended Phase 2 dose (RP2D) of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R

Measurement of the time it takes for iadademstat to reach the maximum concentration (Cmax) in blood.

Measurement of the highest concentration of iadademstat in the blood after a dose is given.

Measurement of the lowest concentration of iadademstat in the blood, after a dose is given.

Measurement of how much iadadmestat reaches a person's bloodstream in a given period of time after a dose is given.

Percent of drug covalently bound to LSD1 molecule

Proportion of patients achieving complete remission (CR), CR with incomplete hematologic recovery (CRi), and partial remission (PR).

Time from start of treatment to the time of death from any cause.

Time from start of treatment to the date of failure to achieve CR or CRi, relapse from CR/CRi, or death from any cause, whichever occurs first.

Percentage of patients with complete remission (CR), CR with incomplete blood count recovery (CRi), or PR.

Time from the date of initial dosing at RP2D/expansion dose to first documentation of either a type of CR or Partial Response (PR).

Time from the date of first documentation of any type of remission to the date of first documentation of progression of remission for remitters

A patient is defined as red blood cell (RBC) and/or platelet-transfusion independent if he/she receives no RBC and/or platelet transfusions for a period of at least 8 weeks. Rate of transfusion independence is the percentage of patients who become RBC and/or platelet transfusion independent (from the number of patients transfusion dependent at baseline).

Percentage of patients undergoing Hematopoietic Stem Cell Transplantation (HSCT) during the study period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)	NCT05546580	Acute Myeloid L... Acute Myeloid L...	Iadademstat Gilteritinib Or...	18 Years -	Oryzon Genomics S.A.
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)	NCT05546580	Acute Myeloid L... Acute Myeloid L...	Iadademstat Gilteritinib Or...	18 Years -	Oryzon Genomics S.A.

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