CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
LMB-100 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04034238
NCT04034238Phase 1Completed

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

National Cancer Institute (NCI)·interventional·Posted Jul 26, 2019·Updated Aug 1, 2023

In Brief

A Phase 1 clinical trial evaluating LMB-100, Tofacitinib, and 1 other intervention for Neoplasms With Mesothelin Expression and 3 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 26, 2019
Enrollment StartAug 29, 2019
Primary CompletionDec 1, 2020
Study CompletionNov 19, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago

Interventions

LMB-100drug

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.

Tofacitinibdrug

Arms 1 and 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.

Mesothelin Expressiondevice

Test for mesothelin expression in tumor tissues for study eligibility