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

ConditionsAcute Myelogenous LeukemiaMyelodysplastic Syndromes (MDS)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

266 Participants
are divided into 1 treatment group
Group A: ICP-248 in combination with azacitidineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2.5 years
2

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

Time frame
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.

Time frame
2.5 years
4

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

Time frame
2.5 years

Secondary outcomes

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.

Time frame
2.5 years
2

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

Time frame
2.5 years
3

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

Time frame
2.5 years
4

Maximum concentration (Cmax)of ICP-248.

Time frame
2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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