Study on OT-101 and Pembrolizumab for Treating Malignant Pleural Mesothelioma Not Responding to Checkpoint Inhibitors

Sponsor: Oncotelic Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05425576

Provider View

This clinical trial is testing a new treatment using OT-101 combined with pembrolizumab for patients with malignant pleural mesothelioma that hasn't responded to previous checkpoint inhibitor treatments. The study will evaluate the safety, tolerability, and effectiveness of different doses of OT-101 with pembrolizumab.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining OT-101, a TGF-b2 inhibitor, with pembrolizumab can help treat malignant pleural mesothelioma in patients who have not responded to previous treatments with checkpoint inhibitors. The study will first test different doses to find the safest and most effective one, and then evaluate how well the treatment works in shrinking tumors.

Description

This study is a Phase 2 trial, meaning it is focused on evaluating the effectiveness and safety of the treatment. It is open-label, so both the researchers and participants know what treatment is being given. The study is non-randomized and involves a single group of participants. Initially, the study will test different doses of OT-101 combined with pembrolizumab to determine the best dose for further testing. Participants who receive this dose will continue in the study to see how well the treatment works in controlling the cancer. The treatment involves a continuous intravenous infusion of OT-101 for four days every two weeks, along with pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Must have malignant pleural mesothelioma that has progressed after treatment with checkpoint inhibitors like anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
  • Must be 18 years or older.
  • Male participants must agree to use contraception during the study and for 90 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Must provide written informed consent to participate.
  • Must have measurable disease according to specific criteria.
  • Must provide a biopsy sample before starting treatment.
  • Must have a performance status indicating they are fully active or have some restrictions but can carry out light work.
  • Must have adequate organ function as shown by recent lab tests.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test.
  • Have received other cancer treatments or investigational drugs recently.
  • Have had recent radiotherapy or a live vaccine.
  • Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive treatments.
  • Have another active cancer or a history of severe allergic reactions to pembrolizumab.
  • Have active brain metastases or certain lung diseases.
  • Have active infections or a history of hepatitis B or C.
  • Have any condition that might interfere with the study or are not in the best interest to participate.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Are expecting to conceive or father children during the study or shortly after.
  • Have had a tissue or organ transplant.

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