A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors

Study Identifier
M24-122
CT.gov Identifier
NCT06158958
EudraCT Identifier
Not available
EUCTIS ID
2023-504714-30
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Study Details

Medical Condition
  • Solid Tumors (General)
    • Study Drug
  • ABBV-303
  • Budigalimab
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug. * Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization \[WHO\] criteria). * Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
    Exclusion Criteria:
    * Unresolved Grade \> 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia. * Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy. * History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181). * Body weight \< 35 kg.

    Protocol Summary

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).

    ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.

    In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years.

    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.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 254303
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    University of Southern California /ID# 254356
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    START Midwest /ID# 256945
    Grand Rapids, Michigan, United States, 49546-7062
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 262943
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943
    New York, New York, United States, 10016
    Status
    Not applicable
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