Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1, Open-label, Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Activity of ADCT 301 in Patients With Relapsed or Refractory CD25-positive Acute Myeloid Leukemia (AML) or CD25-positive Acute Lymphoblastic Leukemia
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.
This is a Phase 1 study with ADCT-301 to evaluate the safety, tolerability and
pharmacokinetics of ADCT-301 in participants with Acute Myeloid Leukemia (AML) or Acute
Lymphoblastic Leukemia (ALL).
ADCT-301 is a human monoclonal antibody attached via a cleavable linker to a
pyrrolobenzodiazepine (PBD) warhead which, when internalized by antigen expressing cells,
covalently cross links deoxyribonucleic acid (DNA) preventing replication.
The study will be conducted in 2 parts: In Part 1 (dose escalation) participants will either
be on weekly administration or every 3-week administration. Participants on weekly
administration will receive an infusion of ADCT-301 on Days 1, 8, and 15 of each 3 week
treatment cycle. Participants on 3-week administration will receive an infusion of ADCT-301
on Day 1, every 3 weeks. Dose escalation will continue until the maximum tolerated dose (MTD)
is determined.
In Part 2 (expansion), participants will be assigned to receive a recommended dose and/or
schedule of ADCT-301 as determined by a Dose Escalation Steering Committee.
For each participant, the study will include a screening period (up to 28 days), a treatment
period, and a follow-up period to assess disease progression and survival for up to 12 months
after the last dose of study drug. The total study duration will be dependent on overall
participant tolerability to the study drug and response to treatment. It is anticipated that
the entire study (Parts 1 and 2) will enroll a maximum of 80 participants and could last
approximately 3 years from first participant treated to last participant completed.
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