Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05425576 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Oncotelic.

Not yet
Registry status
Phase 2
Development phase
63
Enrollment target

NCT05425576: Clinical Trial Phase 2 study, sponsored by Oncotelic.

NCT05425576 is a Phase 2 study that has not yet begun recruiting, run by Oncotelic. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05425576, a Phase 2 study, has not yet begun recruiting, sponsored by Oncotelic.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study 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.

Primary Outcome

modified RECIST (mRECIST; v1.1)

Interventions

  • DRUG OT-101

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2025-06
Est. Completion 2029-12
Phase Phase 2
Oncotelic

2 total trials

What is known before NCT05425576 opens enrollment

NCT05425576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which OT-101 is the first listed.

NCT05425576 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05425576 about?

NCT05425576 is a clinical study titled "OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition". 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.

What is the current status of trial NCT05425576?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2025-06. Estimated completion is 2029-12.

What interventions are being tested in trial NCT05425576?

The interventions under investigation include: OT-101 (DRUG).

Who is sponsoring clinical trial NCT05425576?

This trial is sponsored by Oncotelic, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05425576's enrollment target sits among peer trials

63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03383575 · 63 participants · Phase 2

    Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

  • NCT04870944 · 63 participants · Phase 1

    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

  • NCT05031897 · 63 participants · Phase 2

    Two Step Haplo With Radiation Conditioning

  • NCT05312671 · 63 participants · Phase 2

    Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT05425576, the US trial registry maintained by the National Library of Medicine. NCT05425576 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.