Recruiting
Phase 1

ABBV-711 & Budigalimab

Sponsor:

AbbVie

Code:

NCT07241039

Conditions

Advanced Squamous Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-711

Budigalimab

Study Details

Brief 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.

Conditions

Advanced Squamous Tumors

Study ID

NCT07241039

Start date

Nov 20, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: ABBV-711 Monotherapy Dose Escalation

Participants will receive ABBV-711 in escalating doses alone, as part of the 5 year study duration.

experimental: Part 2a: ABBV-711 Monotherapy Dose Expansion

Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration.

experimental: Part 2b: ABBV-711 Monotherapy Dose Expansion

Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration.

experimental: Part 3: ABBV-711 + BudigalimabDose Escalation

Participants will receive ABBV-711 in escalating doses in combination with budigalimab, as part of the 5 year study duration.

experimental: Part 4a: ABBV-711 Budigalimab Dose Expansion

Participants will receive ABBV-711 dose A in combination with budigalimab, as part of the 5 year study duration.

experimental: Part 4b: ABBV-711 Budigalimab Dose Expansion

Participants will receive ABBV-711 dose B in combination with budigalimab, as part of the 5 year study duration.

Interventions

ABBV-711

Oral Tablet

Budigalimab

Intravenous Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 5 Years ]
  • Best overall Response (BOR) [ Time Frame: Up to Approximately 5 Years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City Of Hope Comprehensive Cancer Center /ID# 276550

Recruiting

Duarte, California, United States, 91030

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

Recruiting

Irvine, California, United States, 92618

University of Chicago Medical Center /ID# 276638

Recruiting

Chicago, Illinois, United States, 60637

START Midwest /ID# 272505

Recruiting

Grand Rapids, Michigan, United States, 49546

Carolina BioOncology Institute /ID# 272380

Recruiting

Huntersville, North Carolina, United States, 28078

Next Oncology Dallas /ID# 276659

Recruiting

Irving, Texas, United States, 75039

Princess Margaret Cancer Centre /ID# 276852

Recruiting

Toronto, Ontario, Canada, M5G 2M9

CHUM - Centre hospitalier de l Universite de Montreal /ID# 277586

Recruiting

Montreal, Quebec, Canada, H2X 0A9

More Information

Sponsor

AbbVie

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Advanced Squamous Tumors
  • ABBV-711
  • ABBV-181
  • Budigalimab
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Non-Small Cell Lung Cancer
  • sqNSCLC
  • HNSCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-19.