Assessing the effects of ABBV-400 on advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of ABBV-400, an investigational drug, in adult patients with advanced solid tumors such as hepatocellular carcinoma, pancreatic ductal adenocarcinoma, and triple negative breast cancer. Participants will receive ABBV-400 as a monotherapy, followed by a safety follow-up period. The study aims to monitor adverse events and changes in disease activity using established criteria. Approximately 260 adult participants will be enrolled to assess the drug's impact on their conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope National Medical Center /ID# 258645
  Duarte, California, United States Recruiting
• UCSF Medical Center - Mount Zion /ID# 257705
  San Francisco, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialists- Sarasota Cattlemen /ID# 261569
  Sarasota, Florida, United States Recruiting
• Northwestern Medicine - Northwestern Memorial Hospital /ID# 257378
  Chicago, Illinois, United States Recruiting
• University of Chicago Medical Center /ID# 258197
  Chicago, Illinois, United States Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.