A Phase I First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors

Study Identifier:
M24-122
CT.gov Identifier:
NCT06158958
EudraCT Identifier:
202350000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

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Study Summary

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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ABBV-303 Dose Escalation: Part 1A Monotherapy
    • Read More
  • Drug: Experimental: ABBV-303 Dose Escalation: Part 2A Monotherapy
  • Drug: Experimental: ABBV-303 Dose Escalation: Part 3A Monotherapy
  • Drug: Experimental: ABBV-303 Dose Expansion: Part 4A Monotherapy
  • Drug: Experimental: ABBV-303 Dose Expansion: Part 5A Monotherapy
  • Drug: Intervention/treatment
  • Drug: Experimental: ABBV-303 Dose Escalation: Part 1B Combination
  • Drug: Experimental: ABBV-303 Dose Expansion: Part 2B Combination
  • Drug: Drug: Budigalimab
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor