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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: Recruiting Phase 1 study of Epithelial Ovarian Cancer, sponsored by Alexander B Olawaiye, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose-limiting toxicities (DLT) related to E7777 with the immune checkpoint inhibitor (ICI), pembrolizumab. DLT per CTCAE v5.0 will be assessed to determine the RP2D of the treatment combination. Up to twenty patients will be evaluated for DLTs during each dose levels for first 2 cycles (42 days). The transition to next dose level will be determined and planned based on the review of the data on the prior dose level. Safety will be assessed by DLTs, as well as the frequency and severity of immune
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG E7777
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT05200559 shows while recruiting
NCT05200559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 209-participant average among 41 other Epithelial Ovarian Cancer trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05200559's enrollment target sits among peer trials
70 24th of 41 higher than 16 of 41 other Epithelial Ovarian Cancer trials
participants (enrollment target), bucketed by value
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