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NCT07241039 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Advanced Squamous Tumors, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 9
- Study locations
NCT07241039 is a Phase 1 study of Advanced Squamous Tumors that is actively recruiting participants, run by AbbVie. The registered enrollment target is 220 participants. The trial reports 9 study locations across 7 states.
The verdict
NCT07241039, a Phase 1 study of Advanced Squamous Tumors, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 9
- Study locations
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.
Conditions Studied
Interventions
- DRUG Budigalimab
- DRUG ABBV-711
Study Locations (9)
California
- City Of Hope Comprehensive Cancer Center /ID# 276550 - Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432 - Irvine
Other
- Rambam Health Care Campus- Haifa /ID# 276799 - Haifa
- Hadassah Medical Center-Hebrew University /ID# 276800 - Jerusalem
Michigan
- START Midwest /ID# 272505 - Grand Rapids
North Carolina
- Carolina BioOncology Institute /ID# 272380 - Huntersville
Texas
- Next Oncology - Irving /ID# 276659 - Irving
Tel Aviv
- The Chaim Sheba Medical Center /ID# 276798 - Ramat Gan
Osaka
- Kansai Medical University Hospital /ID# 276586 - Hirakata-shi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2025-11-20 |
| Est. Completion | 2030-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07241039
The ClinicalTrials.gov registry entry for NCT07241039 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Squamous Tumors appearing as the primary indexed condition, and to 2 interventions - of which Budigalimab is the first listed.
NCT07241039 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, Other, Michigan.
Frequently Asked Questions
What is clinical trial NCT07241039 about?
NCT07241039 is a clinical study titled "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". 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 s...
What is the current status of trial NCT07241039?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2025-11-20. Estimated completion is 2030-10.
What conditions does trial NCT07241039 study?
This clinical trial studies the following conditions: Advanced Squamous Tumors.
What interventions are being tested in trial NCT07241039?
The interventions under investigation include: Budigalimab (DRUG), ABBV-711 (DRUG).
Who is sponsoring clinical trial NCT07241039?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07241039 being conducted?
This trial has 9 study locations across California, Michigan, North Carolina, Texas, Tel Aviv. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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