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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

RecruitingPhase 1Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 growt

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • ABBV-400
  • Itraconazole (ITZ)
  • Bevacizumab
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Where

54 sites
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- Sarasota Cattlemen /ID# 261569
Sarasota, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 257378
Chicago, United States
University of Chicago Medical Center /ID# 258197
Chicago, United States
START Midwest /ID# 256581
Grand Rapids, United States

โ€ฆand 46 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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