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NCT05703971 | Recruiting | Small Cell Lung Cancer Extensive Stage

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

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

Small Cell Lung Cancer Extensive Stage

Intervention/treatment

quaratusugene ozeplasmid

atezolizumab

Phase

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.}}

Study Type : Interventional
Estimated Enrollment : 62 participants
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)
Actual Study Start Date : April 2024
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : August 2027
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

Biological: atezolizumab

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

Biological: atezolizumab
Ages Eligible for Study: 18 Years
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.
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Colorado

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States, 80124

Recruiting

United States, Missouri

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, missouri, United States, 63110

Recruiting

United States, Oregon

Willamette Valley Cancer Institute (Oregon)

Eugene, Oregon, United States, 97401

Recruiting

United States, Oregon

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States, 97213-2982

Recruiting

United States, Oregon

Providence Cancer Institute

Portland, Oregon, United States, 97213

Recruiting

United States, Oregon

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States, 97227

Recruiting

United States, Oregon

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States, 97223

Recruiting

United States, Texas

Texas Oncology - DFW

dallas, Texas, United States, 75246

Recruiting

United States, Texas

Texas Oncology - Northeast Texas

Tyler, Texas, United States, 75702

Recruiting

United States, Washington

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States, 98684