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
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.
Arms & interventions
- DrugABBV-711
Oral Tablet
- DrugBudigalimab
Intravenous Infusion
Outcome measures
Primary
Number of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 5 Years
Best overall Response (BOR)
BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to Approximately 5 Years
Secondary
Duration of BOR Response
Time frame: Up to Approximately 5 Years
Clinical Benefit Rate (CBR)
Time frame: Up to Approximately 5 Years
Progression-free survival (PFS)
Time frame: Up to Approximately 5 Years
Duration of response (DOR)
Time frame: Up to Approximately 5 Years
Overall survival (OS)
Time frame: Up to Approximately 5 Years
Area Under the Concentration-Time Curve (AUC) of ABBV-711
Time frame: Up to Approximately 5 Years
Maximum Observed Concentration (Cmax) of ABBV-711
Time frame: Up to Approximately 5 Years
Time to Cmax (Tmax) of ABBV-711
Time frame: Up to Approximately 5 Years
Half-Life (t1/2) of ABBV-711
Time frame: Up to Approximately 5 Years
Eligibility criteria
Study locations (6)
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California, 91030
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California, 92618
University of Chicago Medical Center /ID# 276638
Chicago, Illinois, 60637
START Midwest /ID# 272505
Grand Rapids, Michigan, 49546
Carolina BioOncology Institute /ID# 272380
Huntersville, North Carolina, 28078
Next Oncology - Irving /ID# 276659
Irving, Texas, 75039