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RECRUITING
NCT07241039
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2025-11-20

Completion Date

2030-10

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

ABBV-711

Oral Tablet

DRUG

Budigalimab

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