Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT03436732
Brief Summary:
Background:
Mesothelioma is cancer of the tissue that lines some organs. A new drug, LMB-100, may bind to a protein on mesothelioma tumors and kill cancer cells. But sometimes the body makes antibodies that reduce how well LMB-100 works. Researchers want to see if adding the drug SEL-110 to LMB-100 will prevent these antibodies from forming.
Objective:
To learn how safe and tolerable LMB-100 plus SEL-110 is in people with advanced mesothelioma.
Eligibility:
Adults ages 18 and older who have pleural or peritoneal mesothelioma that has not responded to prior platinum-based therapy
Design:
Participants will be screened with
* Medical history
* Physical exam
* Blood and urine tests
* Sample of tumor tissue. This can be from a previous procedure.
* Scan of the chest, abdomen, and pelvis. Participants will lie on a table in a scanner that takes pictures. A special dye may be injected in a vein.
* Positron emission tomography (fludeoxyglucose positron emission tomography (FDG-PET)) scan. A sugar attached to a chemical that gives off a signal will be injected before the scan.
* Heart function tests
The study will be done in 21-day cycles. Participants will get the study drugs for up to 4 cycles. They will get them through an intravenous (IV) catheter (a tube inserted in a vein, usually in the arm):
* LMB-100 for about 30 minutes on day 1, day 3, and day 5 of each cycle
* SEL-110 for about 1 hour on day 1 of each cycle
Participants will get standard medicines to help prevent side effects.
Participants will repeat some screening tests during each cycle and about 5 weeks after the last dose of study drug.
Detailed Description:
Background:
* LMB-100 and a closely related immunotoxin also targeting mesothelin have been studied in previous Phase 1 clinical studies for mesothelioma and pancreatic cancer.
* Results from these studies showed that the majority of patients formed anti-drug-antibodies (ADAs) that neutralized subsequent injection of the product making it ineffective.
* In a small subset of patients that did not form ADAs to the product, good response and regression of tumors was seen.
* In a different application SEL-110, a biodegradable nanoparticle containing rapamycin, has been shown in clinical trials to prevent the formation of ADAs to an immunogenic enzyme when co-administered. Preclinical data show that SEL-110 also prevents the formation of ADAs to LMB-100.
* This clinical trial will investigate whether SEL-110 when administered with LMB-100 is able to prevent the formation of ADAs and thus allow patients to receive multiple, effective injections of LMB-100.
Objectives:
-The primary objective of the study is to assess the safety and tolerability of LMB-100 in combination with SEL-110.
Eligibility:
Primary Inclusion Criteria
* Greater than or equal to 18 years of age
* Histologically confirmed epithelial or biphasic pleural or peritoneal mesothelioma not amenable to potentially curative surgical resection.
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin. There is no limit to the number of prior chemotherapy regimens received.
* Patients for whom no standard curative therapy exists
Primary Exclusion Criteria:
* Known or clinically suspected central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases.
* Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results.
* Evidence of active or uncontrolled infections.
* Live attenuated vaccinations 14 days prior to treatment
* Pregnant women are excluded from this study
Design:
* This is a Phase I, single center, dose escalation study of LMB-100 in combination with SEL-110
* Patients will receive the combination using a dose escalation scheme in which different doses of LMB100 and SEL-110 will be evaluated.
* Patients will receive 4 cycles of LMB-100 with SEL-110. A cycle will consist of intravenous (i.v.) infusion of SEL-110 on Day 1 of the cycle followed immediately by an i.v. infusion of LMB-100, then on Days 3 and 5 of the cycle patients will receive an i.v. infusion of LMB-100 only. Treatment cycles will be separated by 21 days.
Study:
NCT03436732
Study Brief:
Protocol Section:
NCT03436732