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NCT05200559 · ClinicalTrials.gov registry record · Phase 1

T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors

A Phase 1 study of Epithelial Ovarian Cancer, sponsored by Alexander B Olawaiye, MD.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT05200559 is a Phase 1 study of Epithelial Ovarian Cancer that is actively recruiting participants, run by Alexander B Olawaiye, MD. The registered enrollment target is 70 participants, below the 209-participant average among 41 other Epithelial Ovarian Cancer trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05200559, a Phase 1 study of Epithelial Ovarian Cancer, is actively recruiting participants, sponsored by Alexander B Olawaiye, MD.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Epithelial ovarian cancer (OC) is the most lethal gynecologic cancer: nearly 22,000 women are diagnosed with OC in the US annually and 63% are expected to die from their disease. The 5-year overall survival rate is unacceptably low at 20-30%, with \> 50% of patients experiencing recurrence of their disease. Recurrent, platinum-resistant OC is characterized by a low response to chemotherapy (\<10-15%) and poor prognosis, with overall survival estimated to be \<12 months. Thus, there is an urgent need to identify novel therapies to improve outcomes for patients with recurrent, platinum resistant OC. The primary focus in this trial is targeting tumor associated immunosuppressive T-regs with E7777 combined with PD-1 inhibitor, pembrolizumab. This trial will enroll patients with solid tumors in the dose escalation portion and specified cohorts in the dose expansion portion. In the Phase I portion, 18-30 patients will be enrolled. In the dose expansion portion, approximately 40 patients (20 in each cohort) will be enrolled. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.

Conditions Studied

Epithelial Ovarian Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG E7777

Study Locations (1)

Pennsylvania

  • UPMC Hillman Cancer Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-09-30
Est. Completion 2027-12
Phase Phase 1

Sponsor

Alexander B Olawaiye, MD

3 total trials

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What the Registry Record Tells You About NCT05200559

The ClinicalTrials.gov registry entry for NCT05200559 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 41 other Epithelial Ovarian Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Alexander B Olawaiye, MD, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epithelial Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05200559 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05200559 about?

NCT05200559 is a clinical study titled "T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors". Epithelial ovarian cancer (OC) is the most lethal gynecologic cancer: nearly 22,000 women are diagnosed with OC in the US annually and 63% are expected to die from their disease. The 5-year overall survival rate is unacceptably low at 20-30%, with \> 50% of patients experiencing recurrence of their ...

What is the current status of trial NCT05200559?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2022-09-30. Estimated completion is 2027-12.

What conditions does trial NCT05200559 study?

This clinical trial studies the following conditions: Epithelial Ovarian Cancer.

What interventions are being tested in trial NCT05200559?

The interventions under investigation include: Pembrolizumab (DRUG), E7777 (DRUG).

Who is sponsoring clinical trial NCT05200559?

This trial is sponsored by Alexander B Olawaiye, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05200559 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.