AbbVie Expands Oncology Pipeline With First-in-Human ABBV-711 Trial in Advanced Squamous Tumors

Abbvie (ABBV) announced an update on their ongoing clinical study.

Study Overview: AbbVie is running a phase 1, first-in-human trial (NCT07241039) titled “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.” The goal is to test safety, early signs of benefit, and how the new oral drug ABBV-711 moves through the body, both alone and with the antibody budigalimab, in adults with advanced squamous cancers, a group with high unmet medical need. For investors, this is an early but strategic effort to expand AbbVie’s oncology pipeline into difficult solid tumors.

Intervention/Treatment: The study tests two experimental cancer drugs. ABBV-711 is an oral tablet designed to treat solid tumors, given either alone or with other drugs. Budigalimab (ABBV-181) is an intravenous antibody infusion, used here only in combination with ABBV-711. The aim is to find safe dose levels, see how well patients tolerate these medicines, and check whether the combination shows stronger anti-tumor activity than ABBV-711 alone.

Study Design: This is an interventional study with patients randomly assigned to different treatment arms. The model is sequential, meaning the study moves in stages: first testing single-drug dose escalation, then dose expansion in specific cancers, and then repeating the process for the combination. It is open-label, so both doctors and patients know which treatment is given. The main purpose is treatment-focused: to decide if ABBV-711, alone or with budigalimab, is safe enough and active enough to justify larger phase 2 and phase 3 trials.

Study Timeline: The trial was first submitted on November 17, 2025, marking the formal start of regulatory and site setup steps ahead of full enrollment. The estimated total study duration is up to five years, which is normal for a multi-part, dose-escalation oncology trial and implies primary data will emerge gradually as each part completes. The most recent update to the record was filed on January 15, 2026, and the status is currently “recruiting,” signaling that sites are active and patient enrollment is underway. Primary completion and final completion dates have not yet been reached but will be key milestones for safety and early efficacy readouts.

Market Implications: For AbbVie (ABBV), this trial underscores a push to build a broader oncology platform beyond existing revenue drivers such as immunology and hematologic cancer drugs. Early-stage, first-in-human studies do not typically move the stock on their own, but they help support a longer-term growth story and can improve sentiment if investors see a steady flow of innovative assets. The focus on advanced squamous tumors, including squamous non-small cell lung cancer and head and neck cancer, puts AbbVie in direct competition with large oncology players such as Merck, Bristol Myers Squibb, and Roche, which already market checkpoint inhibitors and combination regimens. If ABBV-711, especially in combination with budigalimab, shows promising activity, it could strengthen AbbVie’s negotiating position in future partnerships and add optionality in solid tumors where durable responses remain limited. In the near term, risk is mainly development and execution risk; success or failure will likely impact AbbVie’s valuation over a multi-year horizon rather than in the next few quarters.

The study is currently recruiting and actively updated, with further details available on the ClinicalTrials.gov portal.

To learn more about ABBV’s potential, visit the Abbvie drug pipeline page.