A Multi-center, Phase 1, Open-label, Dose-escalation and Expansion Study of ABBV-383

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Overview

ABBV-383 is a bi-specific antibody, meaning that it interacts with two molecules in your body. One molecule is called B-Cell Maturation Antigen (BCMA) and is found on your multiple myeloma cells. The second is called CD3 and is present on your killer T-cells. When CD3 is engaged on a T cell, it turns the T-cell on and makes it kill whatever cell triggered the activation. Because ABBV-383 sticks very strongly to the BCMA on your myeloma cells, nearby T-cells should specifically attack your tumor cells.

This study is open-label, meaning that everyone on the study will receive ABBV-383. It is a Phase 1, First-in-Human trial, meaning that it is the first study where ABBV-383 will be given to human patients. ABBV-383 is an investigational agent, meaning that it is still being tested for safety and efficacy and has not yet been approved by the FDA.

The purpose of the Study is:

  • To find the highest dose of ABBV-383 that can be given without causing severe side effects.
  • To find out the side effects seen when giving ABBV-383 at different doses.
  • To gather early information about how well ABBV-383 treats myeloma.
  • To measure the amount of ABBV-383 in the blood at different doses.
  • To evaluate biomarkers in your blood or at relevant disease site(s). A biomarker is a substance in your blood or at relevant disease site(s) that may indicate how your disease is progressing or how effective a certain treatment is.
SparkCures ID 998
Trial Phase Phase 1
Enrollment 133 Patients
Treatments
Tags
Trial Sponsors
  • Teneobio Inc.
Trial Collaborators
  • AbbVie
NCT Identifier

NCT03933735

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

US Trial Locations

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