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)

Tarapeutics Science Inc.1 site in 1 country15 target enrollmentSeptember 29, 2021

ConditionsRelapsed or Refractory Acute Myeloid Leukemia (AML)

InterventionsHYML-122

DrugsHYML-122

Overview

Phase: Phase 2
Intervention: HYML-122
Conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML)
Sponsor: Tarapeutics Science Inc.
Enrollment: 15
Locations: 1
Primary Endpoint: ORR
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 29, 2021

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tarapeutics Science Inc.

Responsible Party

Sponsor

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.
•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.

Arms & Interventions

HYML-122 treatment

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).

Intervention: HYML-122

Outcomes

Primary Outcomes

ORR

Time Frame: up to 24 months

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).

composite complete remission (CRc) rate

Time Frame: up to 24 months.

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

Secondary Outcomes

EFS(up to 24 months)
Cmax,ss(at the end of Cycle 1 (each cycle is 28 days))
Cmin,ss(at the end of Cycle 1 (each cycle is 28 days))
RFS(up to 24 months)
OS(up to 24 months)
duration of CR remission(up to 24 months)
AUCss(at the end of Cycle 1 (each cycle is 28 days))
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)(up to 24 months)
Cav,ss(at the end of Cycle 1 (each cycle is 28 days))