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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Squamous Tumors
• Intervention / Treatment: Drug: ABBV-711; Drug: Budigalimab

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre /ID# 276852
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus- Haifa /ID# 276799
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center-Hebrew University /ID# 276800
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 276798
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East /ID# 276585
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital /ID# 276586
• United States
  • California
    • Duarte, California, United States, 91030
      • Recruiting
      • City Of Hope Comprehensive Cancer Center /ID# 276550
    • Irvine, California, United States, 92618
      • Recruiting
      • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center /ID# 276638
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest /ID# 272505
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology Institute /ID# 272380
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • Next Oncology - Irving /ID# 276659

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: ABBV-711; Oral Tablet
Experimental: Part 2a: ABBV-711 Monotherapy Dose Expansion; Participants will receive ABBV-711 dose A alone, as part of the 5 year study duration.	Drug: ABBV-711; Oral Tablet
Experimental: Part 2b: ABBV-711 Monotherapy Dose Expansion; Participants will receive ABBV-711 dose B alone, as part of the 5 year study duration.	Drug: ABBV-711; Oral Tablet
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.	Drug: ABBV-711; Oral Tablet; Drug: Budigalimab; Intravenous Infusion
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.	Drug: ABBV-711; Oral Tablet; Drug: Budigalimab; Intravenous Infusion
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.	Drug: ABBV-711; Oral Tablet; Drug: Budigalimab; Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AE)s	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.	Up to Approximately 5 Years
Best overall Response (BOR)	BOR is defined as partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to Approximately 5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of BOR Response	Duration of response for participants with confirmed PR or better.	Up to Approximately 5 Years
Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with BOR of stable disease (SD) or BOR of PR or better per investigator review according to RECIST version 1.1 criteria.	Up to Approximately 5 Years
Progression-free survival (PFS)	PFS is defined as time from first ABBV-711 to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.	Up to Approximately 5 Years
Duration of response (DOR)	DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 or other criteria to disease progression or death of any cause, whichever occurs earlier.	Up to Approximately 5 Years
Overall survival (OS)	OS is defined as time from first ABBV-711 to death due to any cause.	Up to Approximately 5 Years
Area Under the Concentration-Time Curve (AUC) of ABBV-711	Area under the concentration-time curve of ABBV-711.	Up to Approximately 5 Years
Maximum Observed Concentration (Cmax) of ABBV-711	Maximum observed concentration of ABBV-711.	Up to Approximately 5 Years
Time to Cmax (Tmax) of ABBV-711	Time to Cmax of ABBV-711.	Up to Approximately 5 Years
Half-Life (t1/2) of ABBV-711	Half-life of ABBV-711.	Up to Approximately 5 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Squamous Non-Small Cell Lung Cancer; HNSCC; Head and Neck Squamous Cell Carcinoma; ABBV-181; Budigalimab; sqNSCLC; Advanced Squamous Tumors; ABBV-711
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; budigalimab
• Other Study ID Numbers: M25-632; 2025-521607-48-00 (Ctis: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No