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Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia — INA03  

Mixed Phenotype Acute Leukemia Clinical Trial

Official title:
A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

Clinical Trial Summary

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

Clinical Trial Description

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03957915
Study type Interventional
Source Institut Paoli-Calmettes
Contact Dominique Genre, Dr
Phone (00) 4 91 22 37 78
Email drci.up@ipc.unicancer.fr
Status Recruiting
Phase Early Phase 1
Start date May 29, 2020
Completion date December 28, 2023
View Details
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