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 groupLocations
18Australia
St Vincent's Hospital2010, SydneyNew South Wales, Australia
Royal Perth Hospital6000, PerthWestern Australia, Australia
China
Anhui Provincial Hospita230001, HefeiAnhui, China
Peking University People's Hospital100044, BeijingBeijing Municipality, China
Sponsors and collaborators
Beijing InnoCare Pharma Tech Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov