Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
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 adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony diagnoza zaawansowanego raka (przerzutowego): wątroby, trzustki, dróg żółciowych, przełyku, piersi, głowy i szyi, jajnika lub innych zaawansowanych nowotworów litych
- •Wyniki badań laboratoryjnych spełniające wymagania protokołu
- •Widoczne zmiany nowotworowe możliwe do zmierzenia
- •Pacjent spełnia kryteria aktywności choroby określone w protokole
✗ Disqualifies
- •Przebyta chemioterapia, radioterapia, immunoterapia lub inne leczenie raka w ciągu ostatnich 28 dni
- •Nieopadnięte poważne objawy uboczne z wcześniejszego leczenia raka
- •Historia zapalenia płuc po leczeniu raka wymagająca sterydów
- •Aktywne zapalenie płuc lub podobne choroby płuc
- •Przerzuty do mózgu lub opon mózgowych bez leczenia (chyba że są stabilne)
- •InneCurrentne raki w przeszłości (z pewnymi wyjątkami określonymi w protokole)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (54)
City of Hope National Medical Center /ID# 258645
Duarte, United States
UCSF Medical Center - Mount Zion /ID# 257705
San Francisco, United States
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
Aurora, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver, United States
Florida Cancer Specialists /ID# 261569
Sarasota, United States
Northwestern University Feinberg School of Medicine /ID# 257378
Chicago, United States
University of Chicago Medical Center /ID# 258197
Chicago, United States
START Midwest /ID# 256581
Grand Rapids, United States
Washington University-School of Medicine /ID# 257379
St Louis, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132
New York, United States
Duke Cancer Center /ID# 255129
Durham, United States
Univ Hosp Cleveland /ID# 257706
Cleveland, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Providence, United States
MUSC Hollings Cancer Center /ID# 257935
Charleston, United States
Prisma Health /ID# 257697
Greenville, United States
Tennessee Oncology-Nashville Centennial /ID# 261568
Nashville, United States
MD Anderson Cancer Center /ID# 255131
Houston, United States
Univ Texas HSC San Antonio /ID# 257708
San Antonio, United States
START-San Antonio
San Antonio, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
Fairfax, United States
Chris O'Brien Lifehouse /ID# 262765
Camperdown, Australia
Austin Health /ID# 256635
Heidelberg, Australia
Rabin Medical Center. /ID# 256650
Petah Tikva, Israel
The Chaim Sheba Medical Center /ID# 255731
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center /ID# 258931
Tel Aviv, Israel
Rambam Health Care Campus /ID# 256649
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 256655
Jerusalem, Israel
NHO Nagoya Medical Center /ID# 261001
Nagoya, Japan
Aichi Cancer Center Hospital /ID# 256679
Nagoya, Japan
National Cancer Center Hospital East /ID# 258934
Kashiwa-shi, Japan
Kyoto University Hospital /ID# 256680
Kyoto, Japan
Shizuoka Cancer Center /ID# 257789
Sunto-gun, Japan
National Cancer Center Hospital /ID# 261136
Chuo-Ku, Japan
The Cancer Institute Hospital Of JFCR /ID# 257788
Koto-ku, Japan
Pan American Center for Oncology Trials - Rio Piedras /ID# 262903
Rio Piedras, Puerto Rico
Inje University Haeundae Paik Hospital /ID# 260118
Busan, South Korea
Gyeongsang National University Hospital /ID# 260408
Jinju, South Korea
Chungbuk National University Hospital /ID# 256698
Cheongju-si, South Korea
Seoul National University Hospital /ID# 255730
Seoul, South Korea
Samsung Medical Center /ID# 258933
Seoul, South Korea
Korea University Guro Hospital /ID# 256700
Seoul, South Korea
Institut Catala d Oncologia - ICO - Badalona /ID# 263954
Badalona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 256703
Pamplona, Spain
Hospital HM Nou Delfos /ID# 263953
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 262816
Madrid, Spain
Clinica Universidad de Navarra - Madrid /ID# 264042
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 256702
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 256701
Madrid, Spain
Hospital Quiron Malaga /ID# 263994
Málaga, Spain
Hospital Universitario Miguel Servet /ID# 256704
Zaragoza, Spain
E-DA Cancer Hospital /ID# 258880
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 256712
Taichung, Taiwan
National Taiwan University Hospital /ID# 256713
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 259420
Taoyuan City, Taiwan
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: 8/25/2026.
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