ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
Eligibility criteria
Qualifiers
Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.
Previously treated relapsed/refractory AML subjects
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
For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.
Disqualifiers
R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
Subject has known central nervous system (CNS) leukemia.
Suggest patients with active hepatitis B or C virus infection
Trial design
Treatments tested in this trial
- ICP-248
- Azacitidine
Treatment groups
266 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov