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

Part of paid clinical trials in Orange, California.

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study ID
NCT06656494
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes (MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICP-248 — DRUG
    Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
  • Azacitidine — DRUG
    Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.

Study Details

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.

Key Dates

First listed
Oct 24, 2024
Start date
Dec 18, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
266 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ICP-248 in combination with azacitidine

Primary Outcome Measure

Incidence, type, and severity of dose-limiting toxicity (DLT). [ Time Frame: 2.5 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868-3201
Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Yale University, Yale Cancer CenterNew HavenConnecticut06520
Farah Fasihuddin
[email protected]
(203) 494-4610
H Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612
Fernando Bustamante
[email protected]
813-745-5358
NYU Langone HealthNew YorkNew York10016
Antoine Mesidor
[email protected]
212-263-4403
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-7305
Study Coordinator
[email protected]
+1 919-966-4432
Medical College of WisconsinMilwaukeeWisconsin53226
Medical College of Wisconsin Clinical Trials Office
[email protected]
866-680-0505

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CAYale University, Yale Cancer Center· New Haven, CTH Lee Moffitt Cancer Center & Research Institute· Tampa, FLNYU Langone Health· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCMedical College of Wisconsin· Milwaukee, WI

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