RECRUITING

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

Conditions

Small Cell Lung Cancer Extensive Stage atezolizumab atezolizumab and hyaluronidase-tqjs Tumor Suppressor Gene 2 (TUSC2)Lipid Nanoparticle (LNP)Gene Therapy TECENTRIQ ES-SCLC REQORSA quaratusugene ozeplasmid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-05-09

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05703971

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Sr Director, Clinical Operations

CONTACT

1-877-774-GNPX

kcombs@genprex.com

Chief Medical Officer

CONTACT

1-877-774-GNPX

mberger@genprex.com

Principal Investigator

Mark S Berger, MD

STUDY_DIRECTOR

Genprex, Inc.

Study Locations (Sites)

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, 80124

United States

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, 63110

United States