Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
NCT ID: NCT06084481
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
285 participants
INTERVENTIONAL
2023-11-09
2026-07-31
Brief Summary
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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) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 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 and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Hepatocellular Carcinoma (HCC)
Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 3: Biliary Tract Cancers (BTC)
Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 5: Triple Negative Breast Cancer (TNBC)
Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer
Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Cohort 9: Drug-Drug Interaction
Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
ABBV-400
Intravenous (IV) Infusion
Itraconazole (ITZ)
Oral Solution
Interventions
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ABBV-400
Intravenous (IV) Infusion
Itraconazole (ITZ)
Oral Solution
Eligibility Criteria
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Inclusion Criteria
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization \[WHO\] criteria). Participant meets the criteria for disease activity laid out in the protocol.
Exclusion Criteria
* Unresolved clinically significant AEs \> Grade 1 from prior anticancer therapy.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol.
* History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol.
* Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required.
* History of other active malignancy, with the exception of those laid out in the protocol.
* Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope National Medical Center /ID# 258645
Duarte, California, United States
Ucsf /Id# 257705
San Francisco, California, United States
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
Aurora, Colorado, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver, Colorado, United States
Florida Cancer Specialists /ID# 261569
Sarasota, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 257378
Chicago, Illinois, United States
University of Chicago Medical Center /ID# 258197
Chicago, Illinois, United States
START Midwest /ID# 256581
Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 257379
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
New York, New York, United States
Duke Cancer Center /ID# 255129
Durham, North Carolina, United States
Univ Hosp Cleveland /ID# 257706
Cleveland, Ohio, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Providence, Rhode Island, United States
MUSC Hollings Cancer Center /ID# 257935
Charleston, South Carolina, United States
Prisma Health /ID# 257697
Greenville, South Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 261568
Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 255131
Houston, Texas, United States
Univ Texas HSC San Antonio /ID# 257708
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 260404
San Antonio, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
Fairfax, Virginia, United States
Chris O'Brien Lifehouse /ID# 262765
Camperdown, New South Wales, Australia
Austin Health /ID# 256635
Heidelberg, Victoria, Australia
The Chaim Sheba Medical Center /ID# 255731
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 258931
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 256649
Haifa, , Israel
Hadassah Medical Center-Hebrew University /ID# 256655
Jerusalem, , Israel
Rabin Medical Center. /ID# 256650
Petah Tikva, , Israel
NHO Nagoya Medical Center /ID# 261001
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 256679
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 258934
Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 256680
Kyoto, Kyoto, Japan
Shizuoka Cancer Center /ID# 257789
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 261136
Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 257788
Koto-ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 262903
Rio Piedras, , Puerto Rico
Inje University Haeundae Paik Hospital /ID# 260118
Busan, Busan Gwang Yeogsi, South Korea
Gyeongsang National University Hospital /ID# 260408
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital /ID# 256698
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 255730
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 258933
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital /ID# 256700
Seoul, Seoul Teugbyeolsi, South Korea
Institut Català d'Oncologia (ICO) - Badalona /ID# 263954
Badalona, Barcelona, Spain
Hospital Quirón Málaga /ID# 263994
Málaga, Malaga, Spain
Clinica Universidad de Navarra - Pamplona /ID# 256703
Pamplona, Navarre, 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 Universitario Miguel Servet /ID# 256704
Zaragoza, , Spain
E-DA Cancer Hospital /ID# 258880
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 256713
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 256712
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 259420
Taoyuan, , Taiwan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M24-427
Identifier Type: -
Identifier Source: org_study_id
2023-506227-29-00
Identifier Type: OTHER
Identifier Source: secondary_id