RecruitingPhase 1Phase 2NCT05200559

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

The Efficacy of T-regulatory Cell Depletion with E7777 Combined with Immune Checkpoint Inhibitor, Pembrolizumab, in Recurrent or Metastatic Solid Tumors: Phase I/II Study

Sponsor

Alexander B Olawaiye, MD

Enrollment

70 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Epithelial Ovarian Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — E7777 (which depletes immune-suppressing cells called T-regulatory cells) and pembrolizumab — in people with recurrent or metastatic solid tumors that haven't responded to standard treatments. **You may be eligible if...** - You have a confirmed solid tumor (including melanoma, non-small cell lung cancer, kidney cancer, endometrial cancer, ovarian cancer, or tumors with MSI-high status) - Your cancer has progressed despite standard therapy - Your cancer is measurable on scans - Your organ function meets required levels **You may NOT be eligible if...** - You have active autoimmune disease requiring steroids - You have severe organ dysfunction - You have untreated brain metastases - Prior immunotherapy history may restrict participation depending on the specific drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab is a humanized monoclonal immunoglobulin (Ig) G4 antibody that inhibits lymphocytes PD-1 receptors, blocking the ligands that would deactivate it and prevent an immune response, allowing the immune system to target and destroy cancer cells.

DRUGE7777

E7777 or denileukin diftitox is a recombinant cytotoxic fusion protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met1-Thr387)-His and for human interleukin-2 (Ala1-Thr133), indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the IL-2 receptor.