Trial Title:
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
NCT ID:
NCT05703971
Condition:
Small Cell Lung Cancer Extensive Stage
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Atezolizumab
Conditions: Keywords:
atezolizumab
Tumor Suppressor Gene 2 (TUSC2)
Lipid Nanoparticle (LNP)
Gene Therapy
TECENTRIQ
ES-SCLC
Reqorsa
quaratusugene ozeplasmid
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
quaratusugene ozeplasmid
Description:
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.
Arm group label:
Phase 1
Arm group label:
Phase 2
Other name:
REQORSA
Intervention type:
Biological
Intervention name:
atezolizumab
Description:
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.
Arm group label:
Phase 1
Arm group label:
Phase 2
Other name:
TECENTRIQ
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).
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rocky Mountain Cancer Centers, LLP
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Hege
Email:
jennifer.hege@usoncology.com
Investigator:
Last name:
Robert M Jotte, MD
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Medical Oncology Clinical Call Center
Phone:
314-747-1171
Email:
MedicalOncologyClinicalCallCenter@dom.wustl.edu
Investigator:
Last name:
Daniel Morgensztern, MD
Email:
Principal Investigator
Facility:
Name:
Oncology_Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
David M Waterhouse, MD
Email:
Principal Investigator
Facility:
Name:
Oncology_Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45236
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
David M Waterhouse, MD
Email:
Principal Investigator
Facility:
Name:
Oncology_Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
David M Waterhouse, MD
Email:
Principal Investigator
Facility:
Name:
Oncology_Hematology Care Clinical Trials, LLC
Address:
City:
Cincinnati
Zip:
45245
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
David M Waterhouse, MD
Email:
Principal Investigator
Facility:
Name:
Oncology_Hematology Care Clinical Trials, LLC
Address:
City:
Fairfield
Zip:
45014
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
David M Waterhouse, MD
Email:
Principal Investigator
Facility:
Name:
Willamette Valley Cancer Institute (Oregon)
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeanne Schaffer
Email:
jeanne.schaffer@usoncology.com
Investigator:
Last name:
Bo Wang, MD
Email:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Portland
Zip:
97213-2982
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Thompson
Email:
Jennifer.Thompson@usoncology.com
Investigator:
Last name:
Anthony Van Ho, MD
Email:
Principal Investigator
Facility:
Name:
Providence Cancer Institute
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brenda Fisher, RN
Phone:
503-215-1979
Email:
canrsrchstudies@providence.org
Investigator:
Last name:
Rachel Sanborn, MD
Email:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Thompson
Email:
Jennifer.Thompson@usoncology.com
Investigator:
Last name:
Anthony Van Ho, MD
Email:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Tigard
Zip:
97223
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Thompson
Email:
Jennifer.Thompson@usoncology.com
Investigator:
Last name:
Anthony Van Ho, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - DFW
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Terraciano
Email:
Christine.terraciano@usoncology.com
Investigator:
Last name:
Kartik Konduri, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Northeast Texas
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelly Maxfield
Email:
shelly.maxfield@usoncology.com
Investigator:
Last name:
Donald A Richards, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Friedman
Email:
carrie.friedman@usoncology.com
Investigator:
Last name:
Alexander I Spira, MD
Email:
Principal Investigator
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Thompson
Email:
Jennifer.Thompson@usoncology.com
Investigator:
Last name:
Anthony Van Ho, MD
Email:
Principal Investigator
Start date:
May 9, 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Genprex, Inc.
Agency class:
Industry
Source:
Genprex, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703971
