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

NCT07241039 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: M25-6322025-521607-48-00
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 9

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Duration of BOR Response

  Up to Approximately 5 Years

• Clinical Benefit Rate (CBR)

  Up to Approximately 5 Years

• Progression-free survival (PFS)

  Up to Approximately 5 Years

• Duration of response (DOR)

  Up to Approximately 5 Years

• Overall survival (OS)

  Up to Approximately 5 Years

Study Arms (6)

Part 1: ABBV-711 Monotherapy Dose Escalation

EXPERIMENTAL

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

Drug: ABBV-711

Part 2a: ABBV-711 Monotherapy Dose Expansion

EXPERIMENTAL

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

Drug: ABBV-711

Part 2b: ABBV-711 Monotherapy Dose Expansion

EXPERIMENTAL

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

Drug: ABBV-711

Part 3: ABBV-711 + BudigalimabDose Escalation

EXPERIMENTAL

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

Drug: ABBV-711; Drug: Budigalimab

Part 4a: ABBV-711 Budigalimab Dose Expansion

EXPERIMENTAL

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

Drug: ABBV-711; Drug: Budigalimab

Part 4b: ABBV-711 Budigalimab Dose Expansion

EXPERIMENTAL

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

Drug: ABBV-711; Drug: Budigalimab

Interventions

ABBV-711 DRUG

Oral Tablet

Part 1: ABBV-711 Monotherapy Dose Escalation; Part 2a: ABBV-711 Monotherapy Dose Expansion; Part 2b: ABBV-711 Monotherapy Dose Expansion; Part 3: ABBV-711 + BudigalimabDose Escalation; Part 4a: ABBV-711 Budigalimab Dose Expansion; Part 4b: ABBV-711 Budigalimab Dose Expansion

Budigalimab DRUG

Intravenous Infusion

Part 3: ABBV-711 + BudigalimabDose Escalation; Part 4a: ABBV-711 Budigalimab Dose Expansion; Part 4b: ABBV-711 Budigalimab Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

City Of Hope Comprehensive Cancer Center /ID# 276550

Duarte, California, 91030, United States

RECRUITING

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

Irvine, California, 92618, United States

RECRUITING

START Midwest /ID# 272505

Grand Rapids, Michigan, 49546, United States

RECRUITING

Carolina BioOncology Institute /ID# 272380

Huntersville, North Carolina, 28078, United States

RECRUITING

Next Oncology - Irving /ID# 276659

Irving, Texas, 75039, United States

RECRUITING

The Chaim Sheba Medical Center /ID# 276798

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Rambam Health Care Campus- Haifa /ID# 276799

Haifa, 3525408, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 276800

Jerusalem, 91120, Israel

RECRUITING

Kansai Medical University Hospital /ID# 276586

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); US (5); IL (3)