Actively Recruiting
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
Led by AbbVie · Updated on 2026-02-17
220
Participants Needed
9
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants who have progressed after standard of care therapy or have no curative treatment options
- Participants who have refused, are ineligible for, or intolerant of standard therapies can join
- Prior treatment with PD-1 or PD-L1 targeted agents is allowed
- Must have available tumor tissue samples for gene expression testing or provide fresh biopsy
- For head and neck squamous cell carcinoma participants in backfill parts, consent to paired biopsies is required unless not feasible
- Must have measurable disease based on standard cancer response criteria (RECIST 1.1)
You will not qualify if you...
- Active autoimmune diseases except vitiligo, type 1 diabetes, hypothyroidism, hypopituitarism, or psoriasis not needing systemic treatment
- History of primary immunodeficiency, bone marrow or solid organ transplant
- Active inflammatory bowel disease requiring systemic therapy within past 2 years
- Received cancer therapy including chemotherapy, radiation, immunotherapy, biologics, or investigational drugs within 28 days or 5 half-lives before first ABBV-711 dose
- Radiation therapy to brain metastases within 14 days before first dose
- Use of moderate or strong CYP3A inhibitors or inducers within 14 days or 5 half-lives before first dose
- Need for CYP3A inhibitors or inducers during study
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before or during study
- Use of immunosuppressive medication within 14 days before first dose, except certain steroids at low doses or local use
AI-Screening
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Trial Site Locations
Total: 9 locations
1
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, California, United States, 91030
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, California, United States, 92618
Actively Recruiting
3
START Midwest /ID# 272505
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
Carolina BioOncology Institute /ID# 272380
Huntersville, North Carolina, United States, 28078
Actively Recruiting
5
Next Oncology - Irving /ID# 276659
Irving, Texas, United States, 75039
Actively Recruiting
6
The Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
7
Rambam Health Care Campus- Haifa /ID# 276799
Haifa, Israel, 3525408
Actively Recruiting
8
Hadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, Israel, 91120
Actively Recruiting
9
Kansai Medical University Hospital /ID# 276586
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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