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Study of ABBV-711 and Budigalimab for Advanced Squamous Tumors

This study is looking at two investigational drugs, ABBV-711 and budigalimab (ABBV-181), for adults with advanced squamous tumors. These are cancers that have grown or spread. The study wants to see how safe these drugs are, how well your body handles them, and if they can help shrink tumors. You might receive ABBV-711 alone or in combination with budigalimab. You can join if your cancer has progressed after standard treatments, or if you can't have standard treatments. Even if you've had certain immunotherapy (treatments that use your body's immune system to fight cancer) before, you may still be eligible. The study will track side effects and how much your tumors respond to the treatment for up to five years. About 220 adults will participate worldwide.

Study design
This is an interventional study involving approximately 220 adult participants. It will test ABBV-711 alone and in combination with budigalimab at different doses.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 5 years to measure side effects and tumor response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~220 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:ABBV-711Budigalimab

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AE)s
Measured over Up to Approximately 5 Years
+1 more outcome measured

Conditions

Advanced Squamous Tumors

Explore related trials

Head and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSquamous Cell Carcinoma

Where it's being run

13 sites across 11 states
California2
Israel2
Illinois1
Michigan1
North Carolina1
Texas1
Ontario1
Quebec1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Adverse Events (AE)sUp to Approximately 5 Years

    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.

  • Best overall Response (BOR)Up to Approximately 5 Years

    BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.