OT-101 + Pembrolizumab for Mesothelioma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oncotelic Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with Malignant Pleural Mesothelioma who didn't respond to previous treatments including anti-PD-1/L1 or anti-CTLA-4 antibodies, possibly with chemotherapy. They must have measurable disease, adequate organ function, and agree to contraception. Excluded are those with a recent second cancer, active autoimmune diseases needing treatment within 2 years, severe allergies to pembrolizumab components, certain infections or immunodeficiencies.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 or older with a confirmed diagnosis of Malignant Pleural Mesothelioma.

I can provide a tissue sample from my tumor before starting treatment.

Exclusion Criteria

You have a severe allergic reaction to pembrolizumab or any of the substances it contains.

I have not received a live vaccine in the last 30 days.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Participant Groups

The study tests OT-101 combined with pembrolizumab in patients whose mesothelioma has progressed after checkpoint inhibitor therapy. It aims to evaluate the effectiveness and safety of various doses of OT-101 (a TGF-b2 inhibitor) alongside pembrolizumab.

Group I: Drug OT-101 plus pembrolizumab Experimental Treatment 1 Intervention

OT-101 will be administered at a RP2D dose/m2/day for 4 days continuously and 10 days off every two weeks via a portable infusion pump. Pembrolizumab will be administered with the standard regimen of 400 mg intravenously (IV) every six weeks.

OT-101 is already approved in United States for the following indications:

🇺🇸 Approved in United States as OT-101 for:

• None approved yet; under investigation for pancreatic cancer, glioblastoma, melanoma, and other cancers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

Oncotelic Inc. Lead Sponsor

References