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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

NCT06084481 · AbbVie
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Official title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
About this study
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.
Eligibility criteria
Inclusion Criteria: * Laboratory values meeting the criteria laid out in the protocol. * 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: * Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. * 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.
Study design
Enrollment target: 325 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-11-09
Estimated completion: 2027-09
Last updated: 2026-08-24
Interventions
Drug: ABBV-400Drug: Itraconazole (ITZ)Drug: Bevacizumab
Primary outcomes
  • Objective Response Rate (ORR) (Up to 36 Months)
  • Number of Participants with Adverse Events (AEs) (Up to 36 Months)
  • Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate (Up to 36 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (54)
City of Hope National Medical Center /ID# 258645Active Not Recruiting
Duarte, California, United States
UCSF Medical Center - Mount Zion /ID# 257705Completed
San Francisco, California, United States
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128Completed
Aurora, Colorado, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926Active Not Recruiting
Denver, Colorado, United States
Florida Cancer Specialists /ID# 261569Active Not Recruiting
Sarasota, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 257378Active Not Recruiting
Chicago, Illinois, United States
University of Chicago Medical Center /ID# 258197Active Not Recruiting
Chicago, Illinois, United States
START Midwest /ID# 256581Active Not Recruiting
Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 257379Active Not Recruiting
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132Active Not Recruiting
New York, New York, United States
Duke Cancer Center /ID# 255129Active Not Recruiting
Durham, North Carolina, United States
Univ Hosp Cleveland /ID# 257706Active Not Recruiting
Cleveland, Ohio, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693Active Not Recruiting
Providence, Rhode Island, United States
MUSC Hollings Cancer Center /ID# 257935Completed
Charleston, South Carolina, United States
Prisma Health /ID# 257697Completed
Greenville, South Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 261568Active Not Recruiting
Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 255131Completed
Houston, Texas, United States
Univ Texas HSC San Antonio /ID# 257708Active Not Recruiting
San Antonio, Texas, United States
START-San AntonioRecruiting
San Antonio, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771Completed
Fairfax, Virginia, United States
Chris O'Brien Lifehouse /ID# 262765Completed
Camperdown, New South Wales, Australia
Austin Health /ID# 256635Completed
Heidelberg, Victoria, Australia
Rabin Medical Center. /ID# 256650Completed
Petah Tikva, Central District, Israel
The Chaim Sheba Medical Center /ID# 255731Completed
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 258931Completed
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 256649Active Not Recruiting
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 256655Active Not Recruiting
Jerusalem, Israel
NHO Nagoya Medical Center /ID# 261001Completed
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 256679Completed
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 258934Active Not Recruiting
Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 256680Active Not Recruiting
Kyoto, Kyoto, Japan
Shizuoka Cancer Center /ID# 257789Active Not Recruiting
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 261136Active Not Recruiting
Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 257788Active Not Recruiting
Koto-ku, Tokyo, Japan
Pan American Center for Oncology Trials - Rio Piedras /ID# 262903Completed
Rio Piedras, Puerto Rico
Inje University Haeundae Paik Hospital /ID# 260118Completed
Busan, Busan Gwang Yeogsi, South Korea
Gyeongsang National University Hospital /ID# 260408Completed
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital /ID# 256698Completed
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital /ID# 255730Completed
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 258933Completed
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital /ID# 256700Completed
Seoul, Seoul Teugbyeolsi, South Korea
Institut Catala d Oncologia - ICO - Badalona /ID# 263954Completed
Badalona, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 256703Completed
Pamplona, Navarre, Spain
Hospital HM Nou Delfos /ID# 263953Completed
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 262816Active Not Recruiting
Madrid, Spain
Clinica Universidad de Navarra - Madrid /ID# 264042Completed
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 256702Active Not Recruiting
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 256701Active Not Recruiting
Madrid, Spain
Hospital Quiron Malaga /ID# 263994Completed
Málaga, Spain
Hospital Universitario Miguel Servet /ID# 256704Completed
Zaragoza, Spain
E-DA Cancer Hospital /ID# 258880Active Not Recruiting
Kaohsiung City, Kaohsiung, Taiwan
China Medical University Hospital /ID# 256712Completed
Taichung, Taiwan
National Taiwan University Hospital /ID# 256713Completed
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 259420Completed
Taoyuan City, Taiwan