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Clinical Trial 19870

Cancer Type: Malignant Hematology
Interventions:IMGN632

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Kendra Sweet

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1, Multi-center, Open-label Study of IMGN632 Administered Intravenously in Patients with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Summary

The purpose of this study is to determine the Maximum Tolerated Dose (MTD) and assess the safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

Objective

To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of IMGN632 on the selected dosing schedule(s) (dose escalation) To assess the anti-leukemia activity in BPDCN patients (tumor-specific expansion cohort)

Inclusion Criteria

  • Disease Characteristics and allowable prior therapy:
  • Participants in dose escalation and all expansion cohorts except first relapse AML may have received up to three prior lines of therapy.
  • Dose Escalation - Relapsed or refractory AML (excluding acute promyelocytic leukemia) or BPDCN, based on World Health Organization Classification. All Participants enrolled on this study will have CD123+ disease.
  • Dose Expansion Cohort #1 - Participants will have relapse of CD123+ BPDCN. Participants with prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
  • Dose Expansion Cohort #2 - Participants will have first relapse of CD123+ AML.
  • Dose Expansion Cohort #3 - Participants will have relapse of CD123+ ALL.
  • Dose Expansion Cohort #4 - Participants will have relapse of CD123+ "other" hematologic malignancies not included in the cohorts above (e.g., high-risk/very high-risk MDS, MPN, CMML, CML blast crisis). Other CD123+ malignancies may be considered upon discussion with the Medical Monitor.

  • Exclusion Criteria

  • Participants who, in the judgment of their treating physician, have available standard of care therapies will be excluded
  • AML Participants with active central nervous system (CNS) disease will be excluded.
  • Participants with a history of venous occlusive disease of the liver
  • Participants with a history of Grade 3-4 capillary leak syndrome, or non-cardiac Grade edema are ineligible, e.g., related to SL-401 or other etiology
  • Myocardial infarction within six months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities prior to study entry
  • Participants who have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days or five half-lives, whichever is greater (with exception of hydroxyurea), prior to drug administration on this study.