MedTrace Logo

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma

NCT03436732 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-11-22

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

LMB-100

administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles

DRUG

SEL-110

administered on day 1 of each cycle for up to 4 cycles

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Raffit Hassan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03436732 on ClinicalTrials.gov