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Trying oral ABBV-711 alone and with budigalimab for advanced squamous tumors.

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

Phase 1 Interventional AbbVie · NCT07241039

This trial will test whether oral ABBV-711, alone or with the antibody budigalimab, is safe and can help adults whose advanced squamous tumors have progressed after standard treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, prednisone, budigalimab
Locations9 sites (Duarte, California and 8 other locations)
Trial IDNCT07241039 on ClinicalTrials.gov

What this trial studies

This phase 1 interventional study gives escalating oral doses of ABBV-711 either as a monotherapy or combined with intravenous budigalimab to adults with advanced squamous tumors. Part 1 uses dose escalation to identify tolerated ABBV-711 doses, and later parts treat participants at a selected dose in cohorts such as squamous NSCLC and head and neck squamous cell carcinoma. Approximately 220 participants at roughly 40 global sites will be enrolled, with investigators tracking safety, tolerability, pharmacokinetics and early signs of tumor response. Selected cohorts, particularly HNSCC backfill groups, require paired pre- and on-treatment biopsies to study biological effects.

Who should consider this trial

Good fit: Adults with advanced squamous tumors who have progressed on or after standard-of-care therapy, have no curative options, and can provide required archival or fresh tumor tissue are the intended participants.

Not a fit: Patients who still have curative treatment options, who cannot provide required tumor tissue, or who have medical issues that make them ineligible for a phase 1 protocol are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ABBV-711 alone or with budigalimab could provide a new treatment option that slows tumor growth or produces tumor responses for people with advanced squamous cancers.

How similar studies have performed: Combining targeted oral agents with PD-1 pathway antibodies has shown activity in some cancers, but ABBV-711 itself is investigational and has limited published human efficacy data so far.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).
* Received programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) targeted agents are eligible.
* Confirmation of available archival tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] block or freshly cut slides) or provision of fresh tissue biopsy is required for enrollment in this study for gene expression assessment. If archival tissue requirements cannot be met then the AbbVie therapeutic area Medical Director or designee should be contacted to determine subject eligibility.
* For head and neck squamous cell carcinoma (HNSCC) participants enrolled in backfill (Part 1 and 3), subjects must provide consent to paired biopsies which are pretreatment and on treatment fresh tumor biopsies from the same tumor lesion, unless deemed not feasible by the investigator where upon consultation with the Sponsor is required. Paired biopsies are encouraged (when safe and feasible) but not required for subjects with squamous non-small cell lung cancer (sqNSCLC) enrolled in the backfill (Part 1 and 3).
* Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Exclusion Criteria:

* Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism and psoriasis (not requiring systemic treatment); history of primary immunodeficiency, bone marrow transplantation, or solid organ transplantation. Active inflammatory bowel disease unfit for trial in the opinion of the investigator, including subjects requiring systemic therapy with biologics or immunosuppressive therapy within the past 2 years.
* 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.
  * Radiation therapy for central nervous system metastases within 14 days prior to first dose.
* Subject has systemically used known moderate/strong inhibitors of cytochrome P450 3A (CYP)3A enzyme isoform subfamily within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study treatment.
* Has systemically used known moderate/strong inducers of CYP3A within 14 days prior to the first dose of study treatment.
* Requires treatment with known moderate or strong inhibitors or inducers of CYP3A from the first dose of study treatment and for the duration of the study.
* Administration or consumption of any of the following within 3 days prior to first dose of study treatment and while on study treatment: grapefruit or grapefruit products, Seville oranges (including marmaladecontaining Seville oranges), and star fruit.
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of the study treatment. The following are exceptions to this criterion:

  * Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection);
  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication);
  * Systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent.

Where this trial is running

Duarte, California and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Squamous TumorsABBV-711ABBV-181BudigalimabHead and Neck Squamous Cell CarcinomaSquamous Non-Small Cell Lung CancersqNSCLCHNSCC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.