IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML
18 Years and older, Male and Female
IO-202-CL-001 (primary)
NCI-2020-07121
Summary
To assess safety and tolerability at increasing dose levels of IO-202 in successive cohorts
of participants with AML with monocytic differentiation and CMML in order to estimate the
maximum tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended
Phase 2 dose (RP2D)
Objectives
This is a Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety,
Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Intravenously Administered
IO-202 and IO-202 + Azacitidine ± Venetoclax in Acute Myeloid Leukemia (AML) Patients with
Monocytic Differentiation and in Chronic Myelomonocytic Leukemia (CMML) Patients
Eligibility
- Patients must be =18.
- For the Part 1 Dose-Escalation Phase, patients must be diagnosed with the following:
- Relapsed or refractory AML with myelomonocytic or monoblastic/monocytic differentiation according to the World Health Organization 2016 criteria and has failed treatment with available therapies known to be active for AML.
- Relapsed or refractory CMML and has failed treatment with available therapies known to be active for CMML
- Part 2 Expansion Phase:
- Relapsed or refractory LILRB4high AML with myelomonocytic or monoblastic/monocytic differentiation and has failed treatment with available therapies known to be active for AML.
- Hypomethylating-agent naive CMML regardless of LILRB4 expression levels.
- Newly diagnosed high LILRB4 expression monocytic AML patients considered to be ineligible for standard induction therapy.
- Patients must be amenable to serial BM aspirates/biopsies and peripheral blood sampling during the study.
- Patients must be able to understand and willing to sign an informed consent. A legally authorized representative may consent.
- Patients must have an ECOG performance status of 0 to 2
- Patients must have adequate hepatic function
- Patients must have adequate renal function
- Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.
- Patients must be off systemic calcineurin inhibitors for at least 4 weeks prior to study drug treatment.
- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy.
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