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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: Recruiting Phase 1 study of Advanced Squamous Tumors, sponsored by AbbVie.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT07241039 shows while recruiting
NCT07241039 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher).
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 lists 9 locations in 7 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07241039's enrollment target sits among peer trials
220 230th of 2000 higher than 1,763 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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