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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Oral Tablet
Intravenous Infusion
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California, United States
RECRUITINGCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California, United States
RECRUITINGSTART Midwest /ID# 272505
Grand Rapids, Michigan, United States
RECRUITINGCarolina BioOncology Institute /ID# 272380
Huntersville, North Carolina, United States
RECRUITINGNext Oncology - Irving /ID# 276659
Irving, Texas, United States
RECRUITINGThe Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Tel Aviv, Israel
RECRUITINGRambam Health Care Campus- Haifa /ID# 276799
Haifa, Israel
RECRUITINGHadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, Israel
RECRUITINGKansai Medical University Hospital /ID# 276586
Hirakata-shi, Osaka, Japan
RECRUITINGNumber 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
Duration of BOR Response
Duration of response for participants with confirmed PR or better.
Time frame: Up to Approximately 5 Years
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with BOR of stable disease (SD) or BOR of PR or better per investigator review according to RECIST version 1.1 criteria.
Time frame: Up to Approximately 5 Years
Progression-free survival (PFS)
PFS is defined as time from first ABBV-711 to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time frame: Up to Approximately 5 Years
Duration of response (DOR)
DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 or other criteria to disease progression or death of any cause, whichever occurs earlier.
Time frame: Up to Approximately 5 Years
Overall survival (OS)
OS is defined as time from first ABBV-711 to death due to any cause.
Time frame: Up to Approximately 5 Years
Area Under the Concentration-Time Curve (AUC) of ABBV-711
Area under the concentration-time curve of ABBV-711.
Time frame: Up to Approximately 5 Years
Maximum Observed Concentration (Cmax) of ABBV-711
Maximum observed concentration of ABBV-711.
Time frame: Up to Approximately 5 Years
Time to Cmax (Tmax) of ABBV-711
Time to Cmax of ABBV-711.
Time frame: Up to Approximately 5 Years
Half-Life (t1/2) of ABBV-711
Half-life of ABBV-711.
Time frame: Up to Approximately 5 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.