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OncoMatch/Clinical Trials/NCT05618028

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Is NCT05618028 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ABBV-525 for diffuse large b-cell lymphoma.

Phase 1RecruitingAbbVieNCT05618028Data as of May 2026

Treatment: ABBV-525B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 3 prior lines

Lab requirements

Blood counts

adequate hematological function as defined in the protocol

Liver function

adequate hepatic function as defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Los Angeles Medical Center /ID# 246357 · Los Angeles, California
  • Yale University School of Medicine /ID# 259081 · New Haven, Connecticut
  • Mount Sinai Medical Center-Miami Beach /ID# 248251 · Miami Beach, Florida
  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113 · Fort Wayne, Indiana
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872 · Indianapolis, Indiana

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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