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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
-- Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)
- 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

APTIVATE Trial 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.Check my eligibility
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.See study design
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.

APTIVATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am surgically sterile or had a hysterectomy at least one month ago.
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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 will not donate eggs during and for 3 months after the study.
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I can take pills and am expected to live for at least 3 more months.
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My partner and I are using effective birth control during and 90 days after the study.
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My condition worsened after initially responding to treatment.
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I have waited the required time after my last cancer treatment before starting a new one.
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I agree not to donate sperm from the start of the study until 90 days after the last dose of the study drug.
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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 am a woman who is not pregnant, breastfeeding, and I am using birth control.
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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.

APTIVATE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended Phase 2 dose
Safety of HM43239
Safety of HM43239 in combination with venetoclax
+2 more
Secondary outcome measures
Anti-leukemic activity of HM43239
Anti-leukemic activity of HM43239 in combination with venetoclax
Pharmacodynamic variables
+5 more

APTIVATE Trial Design

4Treatment groups
Experimental Treatment
Group I: Part C Dose Expansion (tuspetinib as a single agent)Experimental Treatment1 Intervention
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.
Group II: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)Experimental Treatment2 Interventions
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.
Group III: Part B Dose ExplorationExperimental Treatment1 Intervention
For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.
Group IV: Part A Dose EscalationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Hanmi Pharmaceutical Company LimitedLead Sponsor
188 Previous Clinical Trials
60,817 Total Patients Enrolled
Aptose Biosciences Inc.Lead Sponsor
7 Previous Clinical Trials
767 Total Patients Enrolled
Naval Daver, MDPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
197 Total Patients Enrolled

Media Library

Tuspetinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03850574 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax), Part A Dose Escalation, Part B Dose Exploration, Part C Dose Expansion (tuspetinib as a single agent)
Acute Myeloid Leukemia Clinical Trial 2023: Tuspetinib Highlights & Side Effects. Trial Name: NCT03850574 — Phase 1 & 2
Tuspetinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850574 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other kinds of trials are similar to this one?

"To date, there has only been one ongoing study for HM43239. This trial is being conducted across 3 cities in 2 different countries. The first ever clinical trial involving HM43239 was completed in 2019 by Aptose Biosciences Inc.. That particular study had 218 participants and successfully navigated Phase 1 & 2 of the drug approval process. In the years since 2019, an additional 34 trials have been carried out."

Answered by AI

Is this the first time that HM43239 has been used in research?

"The drug HM43239 was first trialled in 2019 at Asan Medical Center. To date, there have been a total of 34 completed studies. Out of these, 1 is an active clinical trial with the majority being conducted in Sacramento, California."

Answered by AI

Are we currently enrolling patients for this trial?

"The latest information on clinicaltrials.gov reveals that this trial is ongoing and recruiting patients. The listing was first created on March 11th, 2019 and updated September 13th, 2020."

Answered by AI
~36 spots leftby Mar 2025