IO-202 as Monotherapy and IO-202 Plus Azacitidine in Patients in AML and CMML
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- STATUS
- Recruiting
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- End date
- Mar 16, 2024
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- participants needed
- 119
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- sponsor
- Immune-Onc Therapeutics Inc
Summary
To assess safety and tolerability at increasing dose levels of IO-202 as monotherapy and in combination with Azacitidine in successive cohorts of participants with relapsed or refractory 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) and dose schedule as monotherapy and combination therapy.
Description
This is a Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study of IO-202 as Monotherapy and in combination with Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients with Monocytic Differentiation and in Relapsed/Refractory Chronic Myelomonocytic Leukemia (CMML) Patients.
Details
| Condition | AML M5, AML M4, AML, Nos, Acute Myelogenous Leukemia in Relapse, Myelomonocytic Leukemia, Chronic |
|---|---|
| Treatment | IO-202 Dose Escalation, IO-202 Dose Expansion, IO-202, IO-202 and Azacitidine |
| Clinical Study Identifier | NCT04372433 |
| Sponsor | Immune-Onc Therapeutics Inc |
| Last Modified on | 16 May 2022 |
Eligibility
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