Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
NCT ID: NCT05703971
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
62 participants
INTERVENTIONAL
2024-05-09
2027-08-31
Brief Summary
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The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
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Detailed Description
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Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLTs) will be reviewed by a safety review committee.
Phase 1: Enrollment in Phase 1 is complete and the recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab was determined.
Phase 2: Enrollment has been initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with atezolizumab.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genprex, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark S Berger, MD
Role: STUDY_DIRECTOR
Genprex, Inc.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONC-005
Identifier Type: -
Identifier Source: org_study_id
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