NCT04372433

IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Immune-Onc Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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

Conditions

• AML With Monocytic Differentiation
• CMML

Interventions

Type	Name	Description
BIOLOGICAL	IO-202	IO-202 as monotherapy
BIOLOGICAL	IO-202 and Azacitidine	IO-202 and azacitidine combination therapy
BIOLOGICAL	IO-202 and Azacitidine + Venetoclax	IO-202 and azacitidine + venetoclax combination therapy
BIOLOGICAL	IO-202 and Azacitidine	IO-202 and azacitidine combination therapy

Timeline

• Start date: 2020-09-14
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2020-05-04
• Last updated: 2025-02-14

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study