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TGF-b2 Inhibitor

OT-101 + Pembrolizumab for Mesothelioma

Phase 2

Waitlist Available

Research Sponsored by Oncotelic Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Malignant Pleural Mesothelioma

Must not have

Has known active CNS metastases and/or carcinomatous meningitis

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy exceeding 10 mg daily of prednisone equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new treatment for mesothelioma that combines two drugs. They will assess how well it works and how safe it is.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune-related reactions due to pembrolizumab such as inflammation in organs like lungs (pneumonitis), skin issues, colitis; plus any unknown risks from OT-101 which targets TGF-b2 involved in cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My cancer progressed despite treatment with specific immune therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain metastases or cancer in the lining of my brain.

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I have an immune system disorder or take more than 10 mg of steroids daily.

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I have an autoimmune disease treated with medication in the last 2 years.

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I had radiotherapy less than 2 weeks before starting the study treatment.

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I have or had lung inflammation that needed steroids.

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I am currently being treated for an infection.

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I have a history of Hepatitis B or active Hepatitis C.

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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of ORR for the combination of OT-101 and pembrolizumab in subjects

Secondary study objectives

PFS, DOR and 6-month and 12-month Overall Survival (OS) will be estimated in all subjects in the ITT population.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug OT-101 plus pembrolizumabExperimental Treatment1 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.

0 / 11Eligibility criteria met