RecruitingPhase 1NCT07241039

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


Sponsor

AbbVie

Enrollment

220 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two cancer drugs — ABBV-711 (taken as a pill) alone and in combination with budigalimab (an IV immunotherapy drug) — in adults with advanced squamous cell cancers that have not responded to standard treatments. Squamous cell cancers often arise in the head and neck, lungs, cervix, or skin. **You may be eligible if...** - Your squamous cancer has gotten worse after standard treatments, or you are unable or unwilling to undergo standard treatment - You have already received a PD-1 or PD-L1 immunotherapy drug (or are eligible to) - You can provide a tumor tissue sample (either archived or a fresh biopsy) **You may NOT be eligible if...** - Your cancer type is not a squamous cell carcinoma - You have not received any prior cancer treatment - Your tumor tissue cannot be provided for analysis - You have major organ problems or other conditions that make you ineligible per the study team's assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-711

Oral Tablet

DRUGBudigalimab

Intravenous Infusion


Locations(9)

City Of Hope Comprehensive Cancer Center /ID# 276550

Duarte, California, United States

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

Irvine, California, United States

START Midwest /ID# 272505

Grand Rapids, Michigan, United States

Carolina BioOncology Institute /ID# 272380

Huntersville, North Carolina, United States

Next Oncology - Irving /ID# 276659

Irving, Texas, United States

The Chaim Sheba Medical Center /ID# 276798

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 276799

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 276800

Jerusalem, Israel

Kansai Medical University Hospital /ID# 276586

Hirakata-shi, Osaka, Japan

View Full Details on ClinicalTrials.gov

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NCT07241039