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Venetoclax

For Part A (tuspetinib as a single agent), dose escalation cohort is planned up to 6 dose levels. If a subject in the dose escalation cohort at any dose level achieves clinical response then the dose level will continue to enroll in Part B. If one DLT or less is observed in the 6 patients (\<1/6 DLT observed) in Part A, up to 20 evaluable patients can be enrolled in Part B at that dose level.

For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.

Part C, dose expansion, consists of 2 arms (tuspetinib as a single agent or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the single arm will be 120mg.

Part C, dose expansion, consists of 2 arms (tuspetinib or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the combo arm will be 80mg.

Tuspetinib

Venetoclax will be given to patients in combo treatment group (Part C) either in 50 mg or 100 mg tablets

Venetoclax Oral Tablet

Rafael Bejar, MD, PhD

Pankit Vachhani, MD

Deepa Jeyakumar, MD

Carolyn Mulroney, MD

Eric Tam, MD

Gabriel Mannis, MD

Brian Jonas

Nikolai Podoltsev, MD

Nikolai Podoltsev, MD, PhD

Justin Watts, MD

Martha Arellano

Amir Fathi, MD

Harry Erba, MD

Studipto Mukherjee, MD

Uma Borate, MD

Naval Daver, Dr

Anish Puliyayil, MD

Steven Lane, MD

Hock-Choong Lai, MD

Shuhying Tan, MD

Carolyn Grove, MD

Uwe Platzbecker, MD

Jörg Westermann, MD

Sang-Kyun Sohn

Ho-Jin Shin

Jeong-Ok Lee

Yunksuk Choi, MD

Chul-Won Jung

Leanne Berkahn, MD

Leanna Berkahn, MD

Teresa Bernal

Carmen Martinez Chamorro, MD

Carmen Martinez Chammoro

Olga Salamero, MD

Olga Salamero

Maria Tormo, MD

Pau Montesinos, MD

Naval Daver, MD

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)

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

Three parts in the study - Part A (dose escalation, tuspetinib as a single agent), Part B (dose exploration, tuspetinib as a single agent), Part C (dose expansion, tuspetinib as a single agent and combo arm of tuspetinib with venetoclax)

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

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)

To determine the recommended phase 2 dose based on safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) consideration

Determine the maximum tolerated dose at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML

To determine the frequency and severity of drug-related adverse events across different dose levels when administered in patients with R/R AML

Determine the maximum tolerated dose of HM43239 in combination with venetoclax at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML

To determine the frequency and severity of drug-related adverse events across different dose levels of HM43239 in combination with venetoclax when administered in patients with R/R AML

To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239

To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239 in combination with venetoclax

Pharmacokinetic variables including maximum plasma concentration (Cmax)

Pharmacokinetic variables including minimum plasma concentration (Cmin)

Pharmacokinetic variables including area under the curve (AUC)

Pharmacokinetic variables including volume of distribution

Pharmacokinetic variables including clearance

Determine PD variables by using a plasma inhibitory activity assay (PIA assay) examining the reduction in phospho-STAT5 and phospho-FLT3 in cell lines exposed to plasma from subjects treated in the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia	NCT03850574	Relapsed or Ref...	Tuspetinib Venetoclax Oral...	18 Years -	Aptose Biosciences Inc.
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia	NCT03850574	Relapsed or Ref...	Tuspetinib Venetoclax Oral...	18 Years -	Aptose Biosciences Inc.

Spots Global Cancer Trial Database for tuspetinib

Every month we try and update this database with for tuspetinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tuspetinib

Every month we try and update this database with for tuspetinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tuspetinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.