Recruiting

Phase 1

Phase 2

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

Sponsor:

Genprex, Inc.

Code:

NCT05703971

Conditions

Small Cell Lung Cancer Extensive Stage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

quaratusugene ozeplasmid

atezolizumab

Study Details

Brief 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).

Conditions

Small Cell Lung Cancer Extensive Stage

Study ID

NCT05703971

Start date

May 9, 2024

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or female aged ≥18 years.
Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide
Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.
Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.
Asymptomatic brain metastases must meet ALL criteria of the following (a-d):

1. No history of seizures in the preceding six months.
2. Definitive treatment must be completed ≥21 days prior to enrollment.
3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
4. If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases.

Absolute neutrophil count (ANC) >1500/mm3, platelet count >100,000/mm3 within ≤28 days.
Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days.
Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.
Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.
If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \[β-hCG\]) within ≤7 days of first dose.
FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment.
If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.
Must have voluntarily signed an informed consent in accordance with institutional policies.

Exclusion Criteria:

Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.
Received prior gene therapy.
Received prophylactic cranial irradiation or consolidation thoracic radiation.
Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.
History of autoimmune disease requiring immunosuppression.
History of myocardial infarction or unstable angina within ≤6 months.
Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
Female who is pregnant or breastfeeding

Study Design

Enrollment

62 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1

Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity.

Quaratusugene ozeplasmid doses will be evaluated (0.09 \[starting dose\], and 0.12 mg/kg) until the RP2D is identified.

experimental: Phase 2

Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous \[SQ\] administration once every 21 days) until disease progression or unacceptable toxicity

Interventions

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.

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.

Primary outcome measure

Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1 [ Time Frame: First 21-days at each dose level ]
Progression-Free Survival Rate (PFSR) - Phase 2 [ Time Frame: 18-weeks from Day 1 of maintenance therapy ]

Central Contacts and Locations

Central contacts

Sr Director, Clinical Operations

1-877-774-GNPX kcombs@genprex.com

Chief Medical Officer

1-877-774-GNPX mberger@genprex.com

Locations

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Jennifer Hege

jennifer.hege@usoncology.com

Principal Investigator:

Robert M Jotte, MD

Washington University School of Medicine - Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Medical Oncology Clinical Call Center

314-747-1171 MedicalOncologyClinicalCallCenter@dom.wustl.edu

Principal Investigator:

Daniel Morgensztern, MD

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-417-8231 csmith@gabrailcancercenter.com

Kim Roby

330.492.3345 kroby@gabrailcancercenter.com

Principal Investigator:

Nashat Gabrail, MD

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Cincinnati, Ohio, United States, 45211

Contacts

Douglas Hart

douglas.hart@usoncology.com

Principal Investigator:

David M Waterhouse, MD

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Douglas Hart

douglas.hart@usoncology.com

Principal Investigator:

David M Waterhouse, MD

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Douglas Hart

douglas.hart@usoncology.com

Principal Investigator:

David M Waterhouse, MD

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

Douglas Hart

douglas.hart@usoncology.com

Principal Investigator:

David M Waterhouse, MD

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Fairfield, Ohio, United States, 45014

Contacts

Douglas Hart

douglas.hart@usoncology.com

Principal Investigator:

David M Waterhouse, MD

Willamette Valley Cancer Institute (Oregon)

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Jeanne Schaffer

jeanne.schaffer@usoncology.com

Principal Investigator:

Bo Wang, MD

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97213-2982

Contacts

Jennifer Thompson

Jennifer.Thompson@usoncology.com

Principal Investigator:

Anthony Van Ho, MD

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Brenda Fisher, RN

503-215-1979 canrsrchstudies@providence.org

Principal Investigator:

Rachel Sanborn, MD

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97227

Contacts

Jennifer Thompson

Jennifer.Thompson@usoncology.com

Principal Investigator:

Anthony Van Ho, MD

Northwest Cancer Specialists, P.C.

Recruiting

Tigard, Oregon, United States, 97223

Contacts

Jennifer Thompson

Jennifer.Thompson@usoncology.com

Principal Investigator:

Anthony Van Ho, MD

Texas Oncology - DFW

Recruiting

Dallas, Texas, United States, 75246

Contacts

Christine Terraciano

Christine.terraciano@usoncology.com

Principal Investigator:

Kartik Konduri, MD

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Contacts

Shelly Maxfield

shelly.maxfield@usoncology.com

Principal Investigator:

Donald A Richards, MD

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman

carrie.friedman@usoncology.com

Principal Investigator:

Alexander I Spira, MD

More Information

Sponsor

Genprex, Inc.

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

atezolizumab
atezolizumab and hyaluronidase-tqjs
Tumor Suppressor Gene 2 (TUSC2)
Lipid Nanoparticle (LNP)
Gene Therapy
TECENTRIQ
ES-SCLC
REQORSA
quaratusugene ozeplasmid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genprex, Inc. on 2026-06-03.