OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Oncotelic Inc.
Study ID
NCT05425576
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OT-101 — DRUG
    OT-101 in combination of pembrolizumab

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Mar 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug OT-101 plus pembrolizumab
    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.

Primary Outcome Measure

Determination of ORR for the combination of OT-101 and pembrolizumab in subjects [ Time Frame: approximately 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Melina Marmarelis, MD

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By research site
University of Pennsylvania· Philadelphia, PA

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