RecruitingPhase 1Phase 2NCT05703971

Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Sponsor

Genprex, Inc.

Enrollment

62 participants

Start Date

May 9, 2024

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Extensive Stage

Summary

This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — quaratusugene ozeplasmid (a gene therapy delivered into the lungs) and atezolizumab (an immunotherapy) — as maintenance therapy to keep extensive-stage small cell lung cancer (SCLC) from coming back after initial chemotherapy-immunotherapy treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with extensive-stage small cell lung cancer - Your cancer responded to (or stabilized on) initial treatment with atezolizumab, carboplatin, and etoposide - You have completed 3–4 cycles of that initial treatment - Your performance status is good (ECOG 0 or 1) - Your blood counts, kidney, and liver function are within acceptable ranges - Brain metastases are allowed if stable and off steroids **You may NOT be eligible if...** - Your cancer progressed during initial treatment - You have active or uncontrolled brain metastases - You have had a recent major surgery with complications - Your organ function does not meet minimum requirements 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

BIOLOGICALquaratusugene ozeplasmid

Quaratusugene ozeplasmid is an experimental nonviral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.

BIOLOGICALatezolizumab

Atezolizumab is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death-receptor 1 ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.

Locations(17)

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Gabrail Cancer Center Research

Canton, Ohio, United States