Research Study for Adults with pancreatic adenocarcinoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and mesothelioma

IRB/UVA Tracking #
21982
Principal Investigator
Linda R Duska
Contact
Anne Gabel
Contact Email
Contact Phone
434.982.6657
Official Trial Title
A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients with Advanced Cancers Associated with Mesothelin Expression Who Have Failed Standard Available Therapy
Study Description

The UVA Cancer Center has a clinical trial for adults ages 18 and over who have a type of advanced cancer that is known to express mesothelin (a protein in the MSLN gene), including pancreatic adenocarcinoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and mesothelioma. You will be eligible if you have already been treated with standard therapy and your tumor is now growing.

The purpose of the study is to test the safety and side effects of the MSLN-targeting antibody-based drug, HPN536, and to try to determine the dose of it that would have acceptable side effects and which may be useful in treating patients that have a type of advanced cancer that is known to express mesothelin. If you participate in Phase 1, you may not enroll in Phase 2.

Treatment duration will be about 32 weeks/7 months. It may be shorter if your doctor feels the study drug is no longer helping you. Post-treatment, your study doctor will follow-up with you once a month for the first 6 months, then once every months via phone until the end of the study.

Research-specific tests (ECG, tumor biopsy, blood tests) and the administration of study drug (HPN536) will be provided at no cost to you. The costs of standard tests, procedures, and treatment of complications will be paid by your insurer in the same way as if you were not part of this study. You may be responsible for any extra costs your insurance company does not pay.

Additional information can be found here: NCT03872206

Compensation

No compensation. You may or may not be reimbursed for your travel-related expenses. Please check with the study staff.