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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Choroba nie poddała się leczeniu standardowemu lub brak dostępnej kuracyjnej terapii
- •Wcześniejsze leczenie lekami ukierunkowanymi na białka PD-1/PD-L1 jest dozwolone
- •Dostępne próbki tkanki nowotworu do badań genetycznych (archiwialna lub pobrana świeżo)
- •Mierzalne zmiany nowotworu potwierdzone badaniami obrazowymi
✗ Disqualifies
- •Aktywne choroby autoimmunologiczne (poza bielactwem, cukrzycą typu 1, niedoczynnością tarczycy, niedoborem hormonów przysadki i łuszczycem bez systemowego leczenia)
- •Historia pierwotnego niedoboru odporności, przeszczepu szpiku lub przeszczepu narządu
- •Aktywne zapalenie jelit wymagające terapii biologicznej w ciągu ostatnich 2 lat
- •Poprzednie leczenie chemioterapią, radioterapią lub inną terapią immunologiczną w ostatnich latach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 19, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (13)
City Of Hope Comprehensive Cancer Center /ID# 276550
Duarte, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278432
Irvine, United States
University of Chicago Medical Center /ID# 276638
Chicago, United States
START Midwest /ID# 272505
Grand Rapids, United States
Carolina BioOncology Institute /ID# 272380
Huntersville, United States
Next Oncology Dallas /ID# 276659
Irving, United States
Princess Margaret Cancer Centre /ID# 276852
Toronto, Canada
CHUM - Centre hospitalier de l Universite de Montreal /ID# 277586
Montreal, Canada
The Chaim Sheba Medical Center /ID# 276798
Ramat Gan, Israel
Rambam Health Care Campus- Haifa /ID# 276799
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 276800
Jerusalem, Israel
National Cancer Center Hospital East /ID# 276585
Kashiwa-shi, Japan
Kansai Medical University Hospital /ID# 276586
Hirakata-shi, Japan
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/20/2026.
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