A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT05241106 | Recruiting Phase 2 DMC

• 1 other identifier: HYML-122-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (2)

• ORR

  overall remission rate, including complete remission without minimum residual disease (CRMRD-), complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission without platelet recovery (CRp), partial remission (PR).

  up to 24 months

• composite complete remission (CRc) rate

  CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).

  up to 24 months.

Secondary Outcomes (9)

• RFS

  up to 24 months

• EFS

  up to 24 months

• OS

  up to 24 months

• duration of CR remission

  up to 24 months

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

  up to 24 months

Study Arms (1)

HYML-122 treatment

EXPERIMENTAL

HYML-122 tablets, 200mg spec, 28 days for each cycle. The first eligible three enrolled subjects will be administrated with 600mg bid dose regimen for 28 consecutive days ( 1 treatment cycle). The Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of these three subjects and make decision whether the regimen need to be adjusted (increasing/decreasing administration dosing or adjusting dosing frequency).

Drug: HYML-122

Interventions

HYML-122 DRUG

each treatment cycle is comprised of 28-day consecutive dosing of HYML-122. Upon completion of each cycle, patients may continue to receive oral HYML-122 tablets if they are benefit from the treatment and the toxicity is tolerable.

HYML-122 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarapeutics Science Inc.: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Depei Wu, MD. PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Shu, MD. BS.

CONTACT

86-13918983465; shuyang@tarapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: February 15, 2022
• Study Start: September 29, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)