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

NCT06656494 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes (MDS)

Interventions

DRUG

ICP-248

Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle

DRUG

Azacitidine

Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol,once daily on days 1-7 of each 28-day cycle.

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2027-06-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656494 on ClinicalTrials.gov