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Trial Title:
ICP-248 in Combination with Azacitidine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia(AML) or Previously Treated Relapsed/Refractory Subjects with Acute Myelogenous Leukemia(R/R AML).
NCT ID:
NCT06656494
Condition:
Acute Myelogenous Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-248
Description:
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28
days as one treatment cycle
Arm group label:
ICP-248 in combination with azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Eligible patients will receive azacitidine subcutaneously or intravenously as per the
protocol，once daily on days 1-7 of each 28-day cycle.
Arm group label:
ICP-248 in combination with azacitidine
Summary:
Evaluate the safety, tolerability , pharmacokinetics , and preliminary efficacy of
ICP-248 in Combination with azacitidine in Patients with Acute Myelogenous Leukemia .
This study consists of two parts: Part 1 dose escalation period and Part 2 dose expansion
period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eligible subjects must meet all of the following criteria:
1. Subject must have confirmation of diagnosis of AML, except for acute
promyelocytic leukemia (APL) per 2016 World Health Organization (WHO) criteria.
2. Previously treated relapsed/refractory AML subjects per 2017 European Leukemia
Net (ELN) criteria.
3. Treatment-naïve AML subjects should be:
- ≥60 years of age;OR
- <60 years will be eligible if the subject has at least one of the
following co-morbidities, which make the subject unfit for intensive
chemotherapy:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of
2 - 3;
2. History of congestive heart failure requiring treatment or Ejection
Fraction (EF) ≤ 50% or chronic stable angina;
3. Clinically significant respiratory failure or diffusing capacity for
carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second
(FEV1)
≤ 65%;
4. Creatinine clearance ≥ 30 mL/min to < 45 mL/min (calculated by
Cockcroft Gault formula);
5. Total bilirubin > 1.5 to ≤ 3.0 ×upper limit of normal (ULN);
6. Any other comorbidity that the Investigator judges to be incompatible
with intensive chemotherapy must be reviewed and approved by the
Sponsor medical monitor before study enrollment.
4. Subject must have a projected life expectancy of at least 12 weeks.
5. Subject must have adequate renal function as demonstrated by a creatinine
clearance≥ 30 mL/min; determined via urine collection for 24-hour creatinine
clearance or by the Cockcroft-Gault formula.
6. Subject must have adequate liver function.
Exclusion Criteria:
1. Previously treated subject, who are refractory to previous azacitidine-based therapy
defined as failure to achieve CR/CRi/MLFS per 2017 ELN criteria or intolerable to
previous azacitidine-based treatment defined as discontinuation from
azacitidine-based therapy due to clearly documented toxicity.
2. Previously treated subject, who are refractory to previous BCL-2 inhibitor-based
therapy defined as failure to achieve CR/CRi/MLFS per 2017 ELN criteria or
intolerable to previous BCL-2 inhibitor-based treatment defined as discontinuation
from BCL-2 inhibitor-based therapy due to clearly documented toxicity.
3. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) or
AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1.
4. Subject has known central nervous system (CNS) leukemia.
5. Subject has a history of myeloproliferative neoplasm (MPN) including polycythemia
vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.
6. Subject has a white blood cell count > 25 × 109/L (Cytoreductive therapy for
leucocytosis are permitted to meet this criterion).
7. The serologic status suggestive of active hepatitis B or C virus infection.
8. History of immunodeficiency, including a positive human immunodeficiency virus (HIV)
antibody test.
9. Subjects have another active malignancy within the past 2 years before study entry,
except for who have received curatively treated.
10. History of significant cardiovascular disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
January 2028
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656494
