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

Official title

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

Overview

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.

Interventions

• Drug ABBV-711
  Oral Tablet
• Drug Budigalimab
  Intravenous Infusion

Primary outcome measures

• 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]

Secondary outcome measures (9)

• Duration of BOR Response [Time frame: Up to Approximately 5 Years]
• Clinical Benefit Rate (CBR) [Time frame: Up to Approximately 5 Years]
• Progression-free survival (PFS) [Time frame: Up to Approximately 5 Years]
• Duration of response (DOR) [Time frame: Up to Approximately 5 Years]
• Overall survival (OS) [Time frame: Up to Approximately 5 Years]
• Area Under the Concentration-Time Curve (AUC) of ABBV-711 [Time frame: Up to Approximately 5 Years]
• Maximum Observed Concentration (Cmax) of ABBV-711 [Time frame: Up to Approximately 5 Years]
• Time to Cmax (Tmax) of ABBV-711 [Time frame: Up to Approximately 5 Years]
• Half-Life (t1/2) of ABBV-711 [Time frame: Up to Approximately 5 Years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 6 centers

• City Of Hope Comprehensive Cancer Center /ID# 276550 — Duarte
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432 — Irvine
• University of Chicago Medical Center /ID# 276638 — Chicago
• START Midwest /ID# 272505 — Grand Rapids
• Carolina BioOncology Institute /ID# 272380 — Huntersville
• Next Oncology - Irving /ID# 276659 — Irving

Israel · 3 centers

• The Chaim Sheba Medical Center /ID# 276798 — Ramat Gan
• Rambam Health Care Campus- Haifa /ID# 276799 — Haifa
• Hadassah Medical Center-Hebrew University /ID# 276800 — Jerusalem

Japan · 2 centers

• National Cancer Center Hospital East /ID# 276585 — Kashiwa-shi
• Kansai Medical University Hospital /ID# 276586 — Hirakata-shi

Canada · 1 center

• Princess Margaret Cancer Centre /ID# 276852 — Toronto

Identifiers

NCT: NCT07241039 · M25-632 · 2025-521607-48-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗