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Tyrosine Kinase Inhibitor

Tuspetinib for Acute Myeloid Leukemia (APTIVATE Trial)

Phase 1 & 2

Recruiting

Led By Naval Daver, MD

Research Sponsored by Hanmi Pharmaceutical Company Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Serum creatinine ≤ 1.5× institutional ULN or an estimated glomerular filtration rate (eGFR) of > 45 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.

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:

Must not have

Patient has BCR-ABL-positive leukemia

Patient has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, HM43239, for patients with relapsed or refractory acute myeloid leukemia (AML). The goal is to find the safe dose range and to see how well the drug works.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) that has come back or didn't respond to previous treatments. They should be in a condition to take oral medication, have an acceptable level of organ function, and not be pregnant or breastfeeding. Participants must use effective contraception and can't join other studies simultaneously.

What is being tested?

The study tests Tuspetinib's safety and how the body responds to it at different doses in AML patients. It's given alongside Venetoclax tablets in an open-label format where everyone knows what treatment they're getting.

What are the potential side effects?

Possible side effects include changes in liver enzymes, digestive issues, fatigue, potential heart rhythm problems (QT prolongation), increased risk of infection including hepatitis B/C or HIV, and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine or eGFR, is within the required range.

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My leukemia is confirmed as AML according to WHO criteria.

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I can take pills and am expected to live for at least 3 more months.

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My condition worsened after initially responding to treatment.

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My condition did not improve after at least one treatment cycle.

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I am not breastfeeding and will not for 90 days after the last study drug.

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I can take care of myself and perform daily activities.

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I have not had a menstrual period for at least 1 year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My leukemia is BCR-ABL positive.

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I have significant heart rhythm issues as shown on an ECG.

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I cannot or will not stop taking medications that may affect my heart's rhythm.

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I do not have any active infections, including COVID-19.

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My cancer has spread to my brain or spinal cord.

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I received radiation therapy less than 4 weeks ago.

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I have a condition or family history that increases my risk of heart rhythm problems.

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I have not had major surgery in the last 4 weeks.

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I am being treated for a serious condition where my transplant is attacking my body.

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I have been diagnosed with acute promyelocytic leukemia.

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I have a cancer diagnosis that is not AML or MDS.

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I have lasting side effects from previous AML treatment that still affect me.

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I have an active hepatitis B or C infection, or another liver condition.

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I have lasting side effects from a transplant that affect my daily life.

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I have a history of heart problems.

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I have a blood clotting disorder known as DIC.

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I had a severe reaction to a cancer drug targeting enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration-time curve (AUC)

Maximum plasma concentration (Cmax)

Maximum tolerated dose (MTD) of tuspetinib

+6 more

Secondary study objectives

Complete remission (CR)

Complete remission with incomplete hematologic recovery (CRi)

Complete remission with incomplete platelet recovery (CRp)

+7 more

Other study objectives

Mutation status of genes after treatment with tuspetinib

Percent inhibition of phosphorylation of targeted proteins

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part D Dose Exploration (tuspetinib plus venetoclax and azacitidine) [ACTIVE, NOT RECRUITING]Experimental Treatment3 Interventions

Part D dose exploration of tuspetinib in combination with venetoclax and azacitidine is planned for up to 6 dose levels. The initial tuspetinib dose will be 40 mg.

Group II: Part C Dose Expansion (tuspetinib plus venetoclax) [ACTIVE, NOT RECRUITING]Experimental Treatment2 Interventions

Part C dose expansion of tuspetinib in combination with venetoclax is planned for 2 dose levels. The initial tuspetinib dose will be 80 mg.

Group III: Part C Dose Expansion (tuspetinib as a single agent) [ACTIVE, NOT RECRUITING]Experimental Treatment1 Intervention

Part C dose expansion of tuspetinib as a single agent is planned for 2 dose levels. Study participants will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose will be 120 mg.

Group IV: Part B Dose Exploration [ACTIVE, NOT RECRUITING]Experimental Treatment1 Intervention

Part B dose exploration of tuspetinib as a single agent is planned for up to 4 dose levels.

Group V: Part A Dose Escalation [COMPLETED]Experimental Treatment1 Intervention

Part A dose escalation of tuspetinib as a single agent is planned for up to 6 dose levels. If a study participant in dose escalation 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 participants (\<1/6 DLT observed) in Part A, up to 20 evaluable participants can be enrolled in Part B at that dose level.

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