M24-427 A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

The purpose of this study is to determine the safety of ABBV-400 at a certain dose level, to see how much ABBV-400 is in your blood at various times (these tests are called "pharmacokinetics" or "PK"), and to determine if study treatment with ABBV-400  has an effect on tumor growth in different types of solid tumor cancers. This study is for subjects with advanced or metastatic hepatocellular carcinoma (HCC), biliary tract cancer (BTC), pancreatic ductal adenocarcinoma (PDAC), esophageal squamous cell carcinoma (ESCC), triple negative (TN) breast cancer (BC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) BC, and head and neck squamous cell carcinoma (HNSCC).

Inova Schar Cancer
8081 Innovation Park Drive
Fairfax, VA 22031

• 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), or head and neck squamous-cell-carcinoma (HNSCC) (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol.

• 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 AEs > Grade 1 from prior anticancer therapy except for alopecia.
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor 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.