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RECRUITING
NCT05703971
PHASE1/PHASE2

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

Sponsor: Genprex, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-05-09

Completion Date

2027-08

Last Updated

2025-10-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

quaratusugene 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.

BIOLOGICAL

atezolizumab

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

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States

Oncology_Hematology Care Clinical Trials, LLC

Fairfield, Ohio, United States

Willamette Valley Cancer Institute (Oregon)

Eugene, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Providence Cancer Institute

Portland, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States

Texas Oncology - DFW

Dallas, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States