OncoMatch/Clinical Trials/NCT07241039
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
Is NCT07241039 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ABBV-711 and Budigalimab for advanced squamous tumors.
Treatment: ABBV-711 · Budigalimab — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: standard of care therapy
Must have progressed on or after standard of care therapy and have no curative therapy available (participants who have refused, are considered ineligible for or are intolerant to standard of care therapy are eligible)
Cannot have received: anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic, investigational therapy)
Exception: palliative radiation therapy for bone, skin or symptomatic metastases with 10 fractions or less is not subject to a washout period
Treatment with any of the following: Anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-711. Palliative radiation therapy for bone, skin or symptomatic metastases with 10 fractions or less is not subject to a washout period.
Cannot have received: radiation therapy for central nervous system metastases
Radiation therapy for central nervous system metastases within 14 days prior to first dose.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City Of Hope Comprehensive Cancer Center /ID# 276550 · Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432 · Irvine, California
- START Midwest /ID# 272505 · Grand Rapids, Michigan
- Carolina BioOncology Institute /ID# 272380 · Huntersville, North Carolina
- Next Oncology - Irving /ID# 276659 · Irving, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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