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A Phase 1 first‑in‑human study evaluating safety, pharmacokinetics, and efficacy of ABBV‑787 in adult subjects with acute myeloid leukemia (AML)

Clinical Trial Details

The purpose of this study is to see if ABBV-787 (the study drug) is safe and to determine if ABBV-787 has an effect on relapsed or refractory (R/R) Acute Myeloid Leukemia (AML). This study is for patients with Acute Myeloid Leukemia (AML) that have relapsed or are refractory (R/R; meaning they have returned, grown, or progressed during or after one or more prior treatments).

ABBV-787 is considered investigational which means it has not yet been approved by the U.S. Food and Drug Administration (FDA).

ABBV-787 will be given through an IV and all participants will receive the same dose. The study visits for the dose will be given on Cycle 1 Day 1, Cycle 2 Day 2, Cycle 3 day 1, and Cycle 4 day 1.

The planned length of study participation is 3 years.

Key Eligibility: 

Inclusion Criteria:

  1. A confirmed diagnosis of acute myeloid leukemia (AML)   
  2. Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have been treated with up to 3 prior lines of therapy and are refractory to or intolerant of all established AML therapies that are known to clearly provide clinical benefit at the judgement of the investigator.

Exclusion Criteria:

  1.  Have received a CD33-targeting therapy within 3 months prior to the first dose of ABBV-787.
  2. Stem cell transplant within 3 months prior to first dose of study drug.
  3. Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-787.
  4. History of documented pneumonitis that required treatment with systemic steroids within the last 6 months, nor any evidence of active pneumonitis.

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2311026755

ClinicalTrials.gov:

NCT06068868

Sponsor:

M23‑477

Status

Open to Enrollment

Age Group

Adult

Sponsor