NCT03106428

A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.

Conditions

• Acute Myeloid Leukemia
• Multiple Myeloma
• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	MEDI7247	The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV

Timeline

• Start date: 2017-03-29
• Primary completion: 2020-01-03
• Completion: 2020-01-03
• First posted: 2017-04-10
• Last updated: 2020-02-28

Locations

14 sites across 3 countries: United States, France, South Korea

Regulatory

• FDA-regulated drug study