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

Launched by ABBVIE · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-400 for adults with advanced solid tumors, such as liver cancer, pancreatic cancer, and certain types of breast and ovarian cancers. The main goal is to see how well ABBV-400 works and what side effects it may cause. About 260 adults will take part in the study at various locations around the world. Participants will receive ABBV-400 through an intravenous (IV) infusion for up to two years, followed by a safety follow-up period lasting up to another two years. Throughout the trial, their health will be closely monitored to check for any changes in their disease and to report any side effects.

To be eligible for this trial, participants must have a documented diagnosis of one of the specified advanced cancers and meet certain health criteria. They should not have received any other cancer treatments within a month prior to starting the study. Participants can expect regular hospital visits for check-ups, blood tests, and questionnaires about their health during the trial. It’s important to note that this study may involve more frequent medical visits and monitoring compared to standard cancer care.

Gender

ALL

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.