Evaluating HYML-122 for FLT3 Positive Acute Myeloid Leukemia

a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

This study is testing a new drug called HYML-122 to see if it can help people with FLT3 positive acute myeloid leukemia who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tarapeutics Science Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05241106 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter phase 2 study aimed at assessing the efficacy, safety, and pharmacokinetics of HYML-122 monotherapy in patients with FLT3 positive relapsed or refractory acute myeloid leukemia (AML). The study will enroll Chinese subjects who have histologically confirmed AML and have either not responded to prior chemotherapy or have relapsed after achieving remission. Participants will receive HYML-122 and will be monitored for treatment outcomes and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with FLT3 positive relapsed or refractory AML.

Not a fit: Patients who do not have FLT3 mutations or those with other types of leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a challenging form of leukemia.

How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting FLT3 mutations in AML have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
* Males and/or females at least 18 years old when signing the informed consent form.
* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:

Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.

* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.
* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
* Life expectancy of at least 3 months.
* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.

Exclusion Criteria:

* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).
* Medical history and surgical history excluded according to the protocol.
* Any previous medical treatment history exclude from the protocol.
* Abnormal laboratory results exclude from the protocol.
* Combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol.
* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (mL)\*alcohol content (%)\*0.8.
* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.
* History of drug abuse or drug addicts.
* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.

Where this trial is running

Suzhou, Jiangsu

• the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Depei Wu, MD. PhD — The First Affiliated Hospital of Soochow University
• Study coordinator: Yang Shu, MD. BS.

Conditions Relapsed or Refractory Acute Myeloid Leukemia