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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT05703971Sponsor: Genprex, Inc.Last updated: 2026-06-03

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).

Detailed description

Acclaim-3 is an open-label, multi-center, Phase 1/2 study evaluating the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with ES-SCLC who did not develop tumor progression after receiving at least 3 cycles, and no more than 4 cycles, of induction therapy with carboplatin plus etoposide and atezolizumab. 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.

Arms & 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.

Outcome measures

Primary

  • 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).

    Time frame: 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).

    Time frame: 18-weeks from Day 1 of maintenance therapy

Secondary

  • Safety Profile - Phase 1

    Time frame: Approximately 6 months

  • Progression-free Survival (PFS) - Phase 1 & Phase 2

    Time frame: Approximately 5 months

  • Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2

    Time frame: First 21-day treatment cycle

  • Overall Survival (OS) - Phase 1 & Phase 2

    Time frame: Approximately 18 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (17)

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124

Recruiting
Jennifer Hege · Contact
Robert M Jotte, MD · Principal Investigator

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting
Medical Oncology Clinical Call Center · Contact
Daniel Morgensztern, MD · Principal Investigator

Gabrail Cancer Center Research

Canton, Ohio, 44718

Recruiting
Nashat Gabrail, MD · Principal Investigator

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45211

Recruiting
Douglas Hart · Contact
David M Waterhouse, MD · Principal Investigator

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45236

Recruiting
Douglas Hart · Contact
David M Waterhouse, MD · Principal Investigator

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45242

Recruiting
Douglas Hart · Contact
David M Waterhouse, MD · Principal Investigator

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, 45245

Recruiting
Douglas Hart · Contact
David M Waterhouse, MD · Principal Investigator

Oncology_Hematology Care Clinical Trials, LLC

Fairfield, Ohio, 45014

Recruiting
Douglas Hart · Contact
David M Waterhouse, MD · Principal Investigator

Willamette Valley Cancer Institute (Oregon)

Eugene, Oregon, 97401

Recruiting
Jeanne Schaffer · Contact
Bo Wang, MD · Principal Investigator

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97213-2982

Recruiting
Jennifer Thompson · Contact
Anthony Van Ho, MD · Principal Investigator

Providence Cancer Institute

Portland, Oregon, 97213

Recruiting
Brenda Fisher, RN · Contact
Rachel Sanborn, MD · Principal Investigator

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227

Recruiting
Jennifer Thompson · Contact
Anthony Van Ho, MD · Principal Investigator

Northwest Cancer Specialists, P.C.

Tigard, Oregon, 97223

Recruiting
Jennifer Thompson · Contact
Anthony Van Ho, MD · Principal Investigator

Texas Oncology - DFW

Dallas, Texas, 75246

Recruiting
Christine Terraciano · Contact
Kartik Konduri, MD · Principal Investigator

Texas Oncology - Northeast Texas

Tyler, Texas, 75702

Recruiting
Shelly Maxfield · Contact
Donald A Richards, MD · Principal Investigator

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031

Recruiting
Carrie Friedman · Contact
Alexander I Spira, MD · Principal Investigator

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684

Terminated