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

Conditions

• Adenocarcinoma, Pancreatic
• Cholangiocarcinoma, Extrahepatic
• Epithelioid Mesothelioma
• Neoplasms With Mesothelin Expression

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LMB-100 — DRUG
  Arms 1 and 2: Administered intravenous (IV) as an approximate 30-minute infusion of each 21-day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.
• Tofacitinib — DRUG
  Arms 1 and 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.
• Mesothelin Expression — DEVICE
  Test for mesothelin expression in tumor tissues for study eligibility

Study Details

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.

Key Dates

Start date

Aug 29, 2019

Status verified

Jul 2023

Primary completion

Dec 1, 2020

Completion

Nov 19, 2021

Study Design

Enrollment

19 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 1. Dose escalation
  LMB-100 at escalating doses plus tofacitinib
• Experimental: 2. Dose expansion
  LMB-100 at optimal dose plus tofacitinib

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of LMB-100 With Tofacitinib [ Time Frame: First cycle of treatment (21 days) ]

Locations (1)

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