ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies

NCT06656494
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
266
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Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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Start date
2024-12-18
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Number of sites
22
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Summary
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
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Short title
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
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Official title
A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-01-01
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First posted
2024-10-24
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Registry last updated
2026-08-18
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Primary completion date
2027-06-01
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Start date
2024-12-18
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Participants
266
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Participant count basis
Estimated
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Planned participants
266
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Protocol amendments
4
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Number of sites
22
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06656494
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ClinicalTrials.gov ID
NCT06656494
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence, type, and severity of dose-limiting toxicity (DLT).

    Timeframe: 2.5 years

  2. Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).

    Timeframe: 2.5 years

  3. The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.

    Timeframe: 2.5 years

  4. AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  5. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  6. MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.

    Timeframe: 2.5 years

  1. AML cohort：Composite complete remission rate: The proportion of subjects with complete remission (CR) and CR with incomplete hematologic recovery (CRi) by Investigator per European Leukemia Net (ELN) 2017 criteria.

    Timeframe: 2.5 years

  2. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  3. The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.

    Timeframe: 2.5 years

  4. Maximum concentration (Cmax)of ICP-248.

    Timeframe: 2.5 years

  5. Area under the curve (AUC) of ICP-248.

    Timeframe: 2.5 years

  6. Time of maximum observed plasma(Tmax)of ICP-248.

    Timeframe: 2.5 years

  7. Trough concentration(Ctrough) of ICP-248.

    Timeframe: 2.5 years

  8. Apparent clearance (CL/F) of ICP-248.

    Timeframe: 2.5 years

  9. AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  10. AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  11. AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  12. AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  13. AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  14. AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.

    Timeframe: 2.5 years

  15. MDS cohort：Modified overall response (mOR) rate, including CR, marrow complete response (mCR), and PR, assessed by Investigator at any time point during the study per revised International Working Group (IWG) 2006 MDS Criteria

    Timeframe: 2.5 years

  16. MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria

    Timeframe: 2.5 years

  17. MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria

    Timeframe: 2.5 years

  18. MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria

    Timeframe: 2.5 years

  19. MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria

    Timeframe: 2.5 years

  20. MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria

    Timeframe: 2.5 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Eligible subjects must meet all of the following criteria:

  1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.

  2. For AML (except for APL) cohort:

    1. Previously treated relapsed/refractory AML subjects
    2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and <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

  3. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.

  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

  1. R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
  2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
  3. Subject has known central nervous system (CNS) leukemia.
  4. Suggest patients with active hepatitis B or C virus infection
  5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
  6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.
Sources for eligibility
clinicaltrials.gov

  • Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, United StatesRecruiting
  • Yale University, Yale Cancer CenterNew Haven, United StatesRecruiting
  • H Lee Moffitt Cancer Center & Research InstituteTampa, United StatesRecruiting
  • NYU Langone HealthNew York, United StatesRecruiting
  • University of North Carolina at Chapel HillChapel Hill, United StatesRecruiting
  • Medical College of WisconsinMilwaukee, United StatesRecruiting
  • St Vincent's HospitalSydney, AustraliaRecruiting
  • Royal Perth HospitalPerth, AustraliaRecruiting
  • Anhui Provincial HospitaHefei, ChinaRecruiting
  • Peking University People's HospitalBeijing, ChinaRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaRecruiting
  • Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
  • Nanfang Hospital Southern Medical UniversityGuangzhou, ChinaRecruiting
  • Henan Cancer HospitalZhengzhou, ChinaRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaRecruiting
  • The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting
  • The First Hospital of Jilin UniversityChangchun, ChinaRecruiting
  • Shengjing Hospital of China Medical UniversityShengyang, ChinaRecruiting
  • Sichuan Provincial People's HospitalChengdu, ChinaRecruiting
  • Tianjin People's HospitalTianjin, ChinaRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (2)