Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients (Acclaim-3)

May 31, 2026 updated by: Genprex, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sr Director, Clinical Operations
  • Phone Number: 1-877-774-GNPX
  • Email: kcombs@genprex.com

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
        • Principal Investigator:
          • Robert M Jotte, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center
        • Principal Investigator:
          • Daniel Morgensztern, MD
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Oncology_Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • David M Waterhouse, MD
      • Cincinnati, Ohio, United States, 45211
        • Recruiting
        • Oncology_Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • David M Waterhouse, MD
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology_Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • David M Waterhouse, MD
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Oncology_Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • David M Waterhouse, MD
      • Fairfield, Ohio, United States, 45014
        • Recruiting
        • Oncology_Hematology Care Clinical Trials, LLC
        • Contact:
        • Principal Investigator:
          • David M Waterhouse, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute (Oregon)
        • Contact:
        • Principal Investigator:
          • Bo Wang, MD
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute
        • Principal Investigator:
          • Rachel Sanborn, MD
        • Contact:
      • Portland, Oregon, United States, 97227
      • Portland, Oregon, United States, 97213-2982
      • Tigard, Oregon, United States, 97223
    • Texas
      • Dallas, Texas, United States, 75246
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Northeast Texas
        • Contact:
        • Principal Investigator:
          • Donald A Richards, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC
        • Contact:
        • Principal Investigator:
          • Alexander I Spira, MD
    • Washington
      • Vancouver, Washington, United States, 98684
        • Terminated
        • Northwest Cancer Specialists, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • REQORSA
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.
Other Names:
  • TECENTRIQ
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
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.
Other Names:
  • REQORSA
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.
Other Names:
  • TECENTRIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
Time Frame: First 21-days at each dose level

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
Time Frame: 18-weeks from Day 1 of maintenance therapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Profile - Phase 1
Time Frame: Approximately 6 months
Adverse events according to CTCAE v5.0
Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
Time Frame: Approximately 5 months
PFS per RECIST 1.1. PFS is defined as time from Day 1 of maintenance therapy to disease progression or death.
Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Time Frame: First 21-day treatment cycle
Concentration of quaratusugene ozeplasmid in whole blood samples.
First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Time Frame: Approximately 18 months
Number of months from Day 1 of maintenance therapy to the date of death.
Approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genprex, Inc.

Investigators

  • Study Director: Mark S Berger, MD, Genprex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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