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

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ClinicalTrials.gov Identifier: NCT05703971
Recruitment Status : Recruiting
First Posted : January 30, 2023
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Genprex, Inc.

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 will be conducted in 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Extensive Stage Biological: quaratusugene ozeplasmid Biological: atezolizumab Phase 1 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: In Phase 1 dose selection, patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with atezolizumab. The recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab will be identified.

Phase 2: Quaratusugene ozeplasmid in combination with atezolizumab will be further evaluated using the RP2D identified in Phase 1.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1: 3+3 dose selection to identify RP2D. Phase 2: open label, non-randomized treatment with quaratusugene ozeplasmid at RP2D in combination with atezolizumab.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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 Name: 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) 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 Name: 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 Name: TECENTRIQ




Primary Outcome Measures :
  1. 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).


  2. 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).


Secondary Outcome Measures :
  1. Safety Profile - Phase 1 [ Time Frame: Approximately 6 months ]
    Adverse events according to CTCAE v5.0

  2. 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.

  3. Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2 [ Time Frame: First 21-day treatment cycle ]
    Concentration of quaratusugene ozeplasmid in whole blood samples.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 3 cycles, and no more than 4 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 be ≥10 days beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc., 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): a. No history of seizures in the preceding 6 months; b. Definitive treatment must be completed ≥21 days prior to enrollment; c. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days; d. 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 ≤21 days.
  • Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤21 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 ≤21 days.
  • Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤21 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 men who are sexually active with FOCBP must agree to use 2 forms of contraception during the study period and for 4 months following the last dose of study treatment.
  • If male, must agree to no sperm donation during study treatment and for an additional 4 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05703971


Contacts
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Contact: Sr Director, Clinical Operations 1-877-774-GNPX kcombs@genprex.com
Contact: Chief Medical Officer 1-877-774-GNPX mberger@genprex.com

Locations
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United States, Colorado
Rocky Mountain Cancer Centers, LLP Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Jennifer Hege       jennifer.hege@usoncology.com   
Principal Investigator: Robert M Jotte, MD         
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Medical Oncology Clinical Call Center    314-747-1171    MedicalOncologyClinicalCallCenter@dom.wustl.edu   
Principal Investigator: Daniel Morgensztern, MD         
United States, Oregon
Willamette Valley Cancer Institute (Oregon) Recruiting
Eugene, Oregon, United States, 97401
Contact: Jeanne Schaffer       jeanne.schaffer@usoncology.com   
Principal Investigator: Bo Wang, MD         
Northwest Cancer Specialists, P.C. Recruiting
Portland, Oregon, United States, 97213-2982
Contact: Jennifer Thompson       Jennifer.Thompson@usoncology.com   
Principal Investigator: Anthony Van Ho, MD         
Providence Cancer Institute Recruiting
Portland, Oregon, United States, 97213
Contact: 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
Contact: Jennifer Thompson       Jennifer.Thompson@usoncology.com   
Principal Investigator: Anthony Van Ho, MD         
Northwest Cancer Specialists, P.C. Recruiting
Tigard, Oregon, United States, 97223
Contact: Jennifer Thompson       Jennifer.Thompson@usoncology.com   
Principal Investigator: Anthony Van Ho, MD         
United States, Texas
Texas Oncology - DFW Recruiting
Dallas, Texas, United States, 75246
Contact: Christine Terraciano       Christine.terraciano@usoncology.com   
Principal Investigator: Kartik Konduri, MD         
Texas Oncology - Northeast Texas Recruiting
Tyler, Texas, United States, 75702
Contact: Shelly Maxfield       shelly.maxfield@usoncology.com   
Principal Investigator: Donald A Richards, MD         
United States, Washington
Northwest Cancer Specialists, P.C. Recruiting
Vancouver, Washington, United States, 98684
Contact: Jennifer Thompson       Jennifer.Thompson@usoncology.com   
Principal Investigator: Anthony Van Ho, MD         
Sponsors and Collaborators
Genprex, Inc.
Investigators
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Study Director: Mark S Berger, MD Genprex, Inc.
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Responsible Party: Genprex, Inc.
ClinicalTrials.gov Identifier: NCT05703971    
Other Study ID Numbers: ONC-005
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genprex, Inc.:
atezolizumab
Tumor Suppressor Gene 2 (TUSC2)
Lipid Nanoparticle (LNP)
Gene Therapy
TECENTRIQ
ES-SCLC
Reqorsa
quaratusugene ozeplasmid
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents