Status:
RECRUITING
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Lead Sponsor:
AbbVie
Conditions:
Hepatocellular Carcinoma
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 gi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06084481
Start Date
November 9 2023
End Date
July 1 2026
Last Update
December 23 2025
Active Locations (54)
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1
City of Hope National Medical Center /ID# 258645
Duarte, California, United States, 91010
2
Ucsf /Id# 257705
San Francisco, California, United States, 94143
3
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
Aurora, Colorado, United States, 80045-7158
4
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver, Colorado, United States, 80218