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
Start Date
11/20/2025
Completion Date
10/1/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-711
Budigalimab
Conditions
Locations
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California 91030
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California 92618
United States
University of Chicago Medical Center /ID# 276638
Chicago, Illinois 60637
United States
START Midwest /ID# 272505
Grand Rapids, Michigan 49546
United States
Carolina BioOncology Institute /ID# 272380
Huntersville, North Carolina 28078
United States
Next Oncology - Irving /ID# 276659
Irving, Texas 75039
United States
Princess Margaret Cancer Centre /ID# 276852
Toronto, Ontario M5G 2M9
Canada
The Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus- Haifa /ID# 276799
Haifa, 3109601
Israel
Hadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, 91120
Israel
National Cancer Center Hospital East /ID# 276585
Kashiwa-shi, Chiba 277-8577
Japan
Kansai Medical University Hospital /ID# 276586
Hirakata-shi, Osaka 573-1191
Japan