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
Public ClinicalTrials.gov record NCT07241039. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07241039
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2025
- Primary completion
- Mar 31, 2029
- Completion
- Sep 30, 2030
- Last update posted
- Aug 18, 2026
2025 – 2030
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City Of Hope Comprehensive Cancer Center /ID# 276550 | Duarte | California | 91030 | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432 | Irvine | California | 92618 | Recruiting |
| University of Chicago Medical Center /ID# 276638 | Chicago | Illinois | 60637 | Recruiting |
| START Midwest /ID# 272505 | Grand Rapids | Michigan | 49546 | Recruiting |
| Carolina BioOncology Institute /ID# 272380 | Huntersville | North Carolina | 28078 | Recruiting |
| Next Oncology Dallas /ID# 276659 | Irving | Texas | 75039 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07241039, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07241039 live on ClinicalTrials.gov.