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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

15mo left

Started May 2024

Typical duration for phase_1

Geographic Reach

1 country

17 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Progress62%

May 2024Aug 2027

First Submitted

Initial submission to the registry

January 19, 2023

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed

1.3 years until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

January 19, 2023

Last Update Submit

October 14, 2025

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

atezolizumabatezolizumab and hyaluronidase-tqjsTumor Suppressor Gene 2 (TUSC2)Lipid Nanoparticle (LNP)Gene TherapyTECENTRIQES-SCLCREQORSAquaratusugene ozeplasmid

Outcome Measures

Primary Outcomes (2)

Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab. Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).
First 21-days at each dose level
Progression-Free Survival Rate (PFSR) - Phase 2
PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
18-weeks from Day 1 of maintenance therapy

Secondary Outcomes (4)

Safety Profile - Phase 1
Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Approximately 18 months

Study Arms (2)

Phase 1

EXPERIMENTAL

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.

Biological: quaratusugene ozeplasmidBiological: atezolizumab

Phase 2

EXPERIMENTAL

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

Biological: quaratusugene ozeplasmidBiological: atezolizumab

Interventions

quaratusugene ozeplasmidBIOLOGICAL

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.

Also known as: REQORSA

Phase 1Phase 2

atezolizumabBIOLOGICAL

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.

Also known as: TECENTRIQ

Phase 1Phase 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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):
No history of seizures in the preceding six months.
Definitive treatment must be completed ≥21 days prior to enrollment.
Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
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.
+3 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Genprex, Inc.lead

Study Sites (17)

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

RECRUITING