Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors

Summary

Background: The protein mesothelin is found on many kinds of tumors. The drug LMB-100 targets cancer cells that make this protein. Researchers want to see if LMB-100 combined with another drug can help people with these tumors. Objective: To find a safe dose of LMB-100 plus tofacitinib in people with pancreatic cancer, bile-duct cancer, and other solid tumors that make mesothelin. Eligibility: People ages 18 and older with pancreatic cancer, bile-duct cancer, or any other solid tumor with mesothelin that worsened after treatment or they could not receive standard treatment Design: Participants will be screened with: * Medical history * Tumor tissue sample. If they do not have a sample, they will have a biopsy. * Physical exam * Blood and heart tests * Scans and x-rays: They may have a dye injected for the scans. Participants will take the drugs in up to three 21-day cycles. They will take tofacitinib by mouth twice a day on days 1-10 of each cycle. They will have LMB-100 injected into the blood on days 4, 6, and 8 of every cycle. Patients that do not have a medi-port may need to have a central vein access line placed. Participants will take other drugs on the days they receive LMB-100. Participants will repeat screening tests during the study. They may have a biopsy at the start of the first 2 cycles. If participants must stop the study, they will have a safety visit 3-6 weeks after their last dose of the study drug. Some participants may then have visits every 6 weeks. After treatment, participants will be contacted about once a year. They will be asked about their cancer.

Timeline

Start

2019-08-29

Primary completion

2020-12-01

Completion

2021-11-19

Publications

• Skorupan N, Peer CJ, Zhang X, Choo-Wosoba H, Ahmad MI, Lee MJ, Rastogi S, Sato N, Yu Y, Pegna GJ, Steinberg SM, Kalsi SS, Cao L, Figg WD, Trepel JB, Pastan I, FitzGerald D, Alewine C. Tofacitinib to prevent anti-drug antibody formation against LMB-100 immunotoxin in patients with advanced mesothelin-expressing cancers. Front Oncol. 2024 Apr 19;14:1386190. doi: 10.3389/fonc.2024.1386190. eCollection 2024.

Drugs

Indications