Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition
Oncotelic Inc.
Summary
This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.
Description
This is a phase 2, open label, non-randomized, single arm Simon's two stage study in subjects with malignant pleural mesothelioma failing to achieve or maintain response to checkpoint inhibition. Before the efficacy assessment portion, the study will first embark a run-in dose-escalation phase to evaluate safety and tolerability of various dose of OT-101 in combination of pembrolizumab, and to determine a recommended Phase 2 dose (RP2D) of 4 days continuous I.V. infusion for every two weeks regimen. Subjects received the RP2D in the run-in dose-escalation phase will be part of the first stage…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have progressed on treatment with an anti-PD-1 or anti-PD-L1 mAb or anti-CTLA-4 mAb administered either as monotherapy or in combination with other therapies including platinum-based chemotherapy. PD-1 treatment progression is defined by meeting all of the following criteria: a. Has demonstrated disease progression after anti-PD-1 or anti-PD-L1 or anti-CTLA-4 mAb as defined by the investigator. 2. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Malignant Ple…
Interventions
- DrugOT-101
OT-101 in combination of pembrolizumab
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania