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

Last updated: February 16, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Head And Neck Cancer

Treatment

Budigalimab

ABBV-711

Clinical Study ID

NCT07241039
M25-632
2025-521607-48-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have progressed on or after standard of care therapy and have no curativetherapy available (participants who have refused, are considered ineligible for orare 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 requiredfor enrollment in this study for gene expression assessment. If archival tissuerequirements cannot be met then the AbbVie therapeutic area Medical Director ordesignee 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 arepretreatment and on treatment fresh tumor biopsies from the same tumor lesion,unless deemed not feasible by the investigator where upon consultation with theSponsor is required. Paired biopsies are encouraged (when safe and feasible) but notrequired for subjects with squamous non-small cell lung cancer (sqNSCLC) enrolled inthe backfill (Part 1 and 3).

  • Evaluable and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Exclusion

Exclusion Criteria:

  • Active autoimmune diseases besides vitiligo, type 1 diabetes, hypothyroidism,hypopituitarism and psoriasis (not requiring systemic treatment); history of primaryimmunodeficiency, bone marrow transplantation, or solid organ transplantation.Active inflammatory bowel disease unfit for trial in the opinion of theinvestigator, including subjects requiring systemic therapy with biologics orimmunosuppressive 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 thedrug (whichever is shorter) prior to the first dose of ABBV-711. Palliativeradiation therapy for bone, skin or symptomatic metastases with 10 fractions orless is not subject to a washout period.

  • Radiation therapy for central nervous system metastases within 14 days prior tofirst 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 priorto the first dose of study treatment.

  • Requires treatment with known moderate or strong inhibitors or inducers of CYP3Afrom 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 firstdose of study treatment and while on study treatment: grapefruit or grapefruitproducts, Seville oranges (including marmaladecontaining Seville oranges), and starfruit.

  • Current or prior use of immunosuppressive medication within 14 days prior to thefirst 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 scanpremedication);

  • Systemic corticosteroids at doses not to exceed 10 mg/day of prednisone orequivalent.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Budigalimab
Phase: 1
Study Start date:
November 20, 2025
Estimated Completion Date:
October 31, 2030

Connect with a study center

  • The Chaim Sheba Medical Center /ID# 276798

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus /ID# 276799

    Haifa 294801, 3525408
    Israel

    Active - Recruiting

  • Rambam Health Care Campus- Haifa /ID# 276799

    Haifa 294801, 3525408
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 276800

    Jerusalem 281184, 91120
    Israel

    Active - Recruiting

  • Kansai Medical University Hospital /ID# 276586

    Hirakata-shi, Osaka 1853904 573-1191
    Japan

    Active - Recruiting

  • City Of Hope Comprehensive Cancer Center /ID# 276550

    Duarte 5344147, California 5332921 91030
    United States

    Active - Recruiting

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • START Midwest /ID# 272505

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Active - Recruiting

  • Carolina BioOncology Institute /ID# 272380

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Next Oncology - Irving /ID# 276659

    Irving 4700168, Texas 4736286 75039
    United States

    Active - Recruiting

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