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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
Sponsor: AbbVie
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-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. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide. In part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 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 questionnaire, medical assessments, blood tests, and scans.
Official title: A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-11-20
Completion Date
2030-10
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
ABBV-711
Oral Tablet
Budigalimab
Intravenous Infusion
Locations (9)
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California, United States
START Midwest /ID# 272505
Grand Rapids, Michigan, United States
Carolina BioOncology Institute /ID# 272380
Huntersville, North Carolina, United States
Next Oncology - Irving /ID# 276659
Irving, Texas, United States
The Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 276799
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, Israel
Kansai Medical University Hospital /ID# 276586
Hirakata-shi, Osaka, Japan