Study of ADCT-301 in Patients With Relapsed/Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia (ALL)

Phase 1 Terminated 35 enrolled ADC Therapeutics S.A.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study evaluates ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Participants will participate in a dose-escalation phase (Part 1) and receive ADCT-301 either weekly or once every 3 weeks. In Part 2 of the study, participants will receive a recommended dose of ADCT-301 as determined by a Dose Escalation Steering Committee.

Timeline

Start: 2016-02-01
Primary completion: 2018-08-29
Completion: 2018-08-29

Outcome

Outcome not reported

Stopped (Enrollment): “Slow enrollment”

Publications

Goldberg AD, Atallah E, Rizzieri D, Walter RB, Chung KY, Spira A, Stock W, Tallman MS, Cruz HG, Boni J, Havenith KEG, Chao G, Feingold JM, Wuerthner J, Solh M. Camidanlumab tesirine, an antibody-drug conjugate, in relapsed/refractory CD25-positive acute myeloid leukemia or acute lymphoblastic leukemia: A phase I study. Leuk Res. 2020 Aug;95:106385. doi: 10.1016/j.leukres.2020.106385. Epub 2020 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADCT-301	Monoclonal antibody	3 ug/kg	Intravenous
Subject	ADCT-301	Monoclonal antibody	30 ug/kg	Intravenous
Subject	ADCT-301	Monoclonal antibody	37.5 ug/kg	Intravenous
Subject	ADCT-301	Monoclonal antibody	92 ug/kg	Intravenous