A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors

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-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors. ABBV-711 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-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. A

Trial Details

NCT ID
NCT07241039
Phase
PHASE1
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • ABBV-711
  • Budigalimab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Huntersville, North Carolina, United States|35.41069,-80.84285
  • Irving, Texas, United States|32.81402,-96.94889

Key Eligibility Criteria

  • Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ine…
  • Received programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) targeted agents are eligible.
  • Confirmation of available archival tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] block or freshly cut slides) or provision of fresh tissu…
  • For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), subjects must provide consent to paired biopsie…

For full eligibility, visit ClinicalTrials.gov.

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