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
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-711: Oral Tablet
Budigalimab: Intravenous Infusion
Study 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
Primary outcome measure(s)
- Number of Participants with Adverse Events (AE)s — Up to Approximately 5 Years
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. - Best overall Response (BOR) — Up to Approximately 5 Years
BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| City Of Hope Comprehensive Cancer Center /ID# 276550 | Duarte | California | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432 | Irvine | California | Recruiting |
| University of Chicago Medical Center /ID# 276638 | Chicago | Illinois | Recruiting |
| START Midwest /ID# 272505 | Grand Rapids | Michigan | Recruiting |
| Carolina BioOncology Institute /ID# 272380 | Huntersville | North Carolina | Recruiting |
| Next Oncology Dallas /ID# 276659 | Irving | Texas | Recruiting |
| Princess Margaret Cancer Centre /ID# 276852 | Toronto | Ontario | Recruiting |
| CHUM - Centre hospitalier de l Universite de Montreal /ID# 277586 | Montreal | Quebec | Recruiting |
| The Chaim Sheba Medical Center /ID# 276798 | Ramat Gan | Tel Aviv | Recruiting |
| Rambam Health Care Campus- Haifa /ID# 276799 | Haifa | Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 276800 | Jerusalem | Israel | Recruiting |
| National Cancer Center Hospital East /ID# 276585 | Kashiwa-shi | Chiba | Recruiting |
| Kansai Medical University Hospital /ID# 276586 | Hirakata-shi | Osaka | Recruiting |
More AbbVie trials in Japan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07241039 on ClinicalTrials.gov ↗ ← All trials in Japan