Mesothelioma Clinical Trial Testing New INBRX-109 Antibody

Microscope with researcher

A new clinical trial is testing an innovative approach to immunotherapy that could change the way antibodies target pleural mesothelioma tumors.

Researchers at eight cancer centers across the U.S. are examining the safety and efficacy of INBRX-109, a unique antibody structure developed to bind with and destroy mesothelioma tumor cells without harming healthy tissue.

Enrollment for mesothelioma patients is ongoing for the second stage of the first-in-humans trial. Safety and efficacy reports are expected in the second quarter of 2020. The first stage of the trial reached its endpoint with no reports of toxicity or intolerance after dose escalation in the first 20 patients.

New Kind of Antibody and Immunotherapy

Inhibrx, a clinical-stage biotechnology company, is sponsoring the clinical trial. The California-based company developed sdAb, a proprietary single domain antibody platform.

In this trial, sdAb targets and activates a receptor called Death Receptor 5 (DR5) on tumor cells.

Activation of DR5 causes cells to self-destruct and results in killing the tumor. However, overactivation of DR5 causes cell death in normal tissues, especially in the liver.

Inhibrx’s new sdAb, labeled INBRX-109, is engineered to only activate the exact number of DR5 receptors that lead to tumor death in mesothelioma cancer cells, while preserving normal cells.

Dr. Katherine Kim, the associate director of research at the Cancer Center of Southern California, discussed the study with The Mesothelioma Center at Asbestos.com.

“Patients are being seen long term without progression of disease,” Kim said. “Some sites have seen drastic shrinkage within the first month or two of treatment.”

How Can You Enroll in the INBRX-109 Clinical Trial?

Mesothelioma patients looking to enroll in this clinical trial can reach out to The Mesothelioma Center’s Patient Advocates for details and resources for enrolling. Patients should also speak with their doctor about participating in a clinical trial to ensure it does not interfere with their current treatment.

It’s important to be informed about the factors involved in a clinical trial before enrolling. The Patient Advocates will connect you with research personnel who can review and discuss the clinical trial information and expectations with you before you make your decision.

Centers Conducting INBRX-109 Trial

  • HonorHealth Research Institute in Scottsdale, Arizona
  • City of Hope in Duarte, California
  • Cancer Center of Southern California in Santa Monica, California
  • University of Colorado Hospital in Aurora, Colorado
  • The University of Chicago in Chicago, Illinois
  • START Midwest Michigan in Grand Rapids, Michigan
  • UT MD Anderson Cancer Center in Houston, Texas
  • NEXT Oncology in San Antonio, Texas

Many of these cancer centers have contracts with the sponsor to provide travel and lodging reimbursements for patients traveling from other states.

Who Is Eligible for the Trial?

A patient’s eligibility often is the largest roadblock faced when enrolling in a clinical trial. Inclusion and exclusion eligibility ensure a patient does not receive experimental medication that would cause more harm than good based on their medical history.

Common eligibility factors include overall health, medical history, past treatment history and current type and stage of mesothelioma.

Eligibility Requirements of INBRX-109 Trial

  • A malignant pleural mesothelioma diagnosis with locally advanced or metastatic disease
  • Adequate organ function defined by blood tests
  • Adequate performance score (the ability to perform daily tasks)
  • No other investigative therapies within four weeks or targeted liver therapy in the past 12 weeks
  • No prior or concurrent malignancies
  • No history of chronic liver disease, significant cardiac conditions, hepatitis or HIV

Researchers can provide additional requirements.

Potential of INBRX-109 and sdAb Platform

During the first stage of the trial, INBRX-109 exhibited similar characteristics to conventional antibodies. This means INBRX-109 is not expected to pose any additional risks than current immunotherapy.

The sdAb platform enables the development of therapeutic compounds with unique mechanisms of action. These antibodies are highly modular and can be combined to create different specificities of cellular activation.

INBRX-109 is leading the way for a new type of immunotherapy that may prove safer and more effective than what’s currently available. If this clinical trial is successful, INBRX-109 will move into Phase II and III clinical trials where it may become more widely available as a neoadjuvant treatment.

Sean Marchese, MS, RN, author for The Mesothelioma Center

Oncology Medical Writer and Registered Nurse

Sean Marchese is a registered nurse and medical writer at The Mesothelioma Center. He has a background in respiratory and thoracic oncology clinical trials. Sean has assisted physicians with the development of chemotherapy and surgical planning for patients with head, neck and thoracic cancers. As a registered nurse, Sean has worked with cancer patients undergoing pain management therapies and patients with brain and nervous system cancers in an inpatient setting.

3 Cited Article Sources

The sources on all content featured in The Mesothelioma Center at Asbestos.com include medical and scientific studies, peer-reviewed studies and other research documents from reputable organizations.

  1. Inhibrx.com. (2019, September 3). Inhibrx Reports Phase 1 Dose Escalation Results of INBRX-109, a Multivalent Agonist of Death Receptor 5.
    Retrieved from: https://inhibrx.com/inhibrx-reports-phase-1-dose-escalation-results-of-inbrx-109-a-multivalent-agonist-of-death-receptor-5/
  2. ClinicalTrials.gov. (2018, October 23). Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas.
    Retrieved from: https://clinicaltrials.gov/ct2/show/NCT03715933?term=inbrx-109&cond=mesothelioma&draw=2&rank=1
  3. Weber, J. S. et al. (2015). Toxicities of immunotherapy for the practitioner. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881375/

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