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).
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
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.
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
RECRUITINGMaximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
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).
Time frame: First 21-days at each dose level
Progression-Free Survival Rate (PFSR) - Phase 2
PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Time frame: 18-weeks from Day 1 of maintenance therapy
Safety Profile - Phase 1
Adverse events according to CTCAE v5.0
Time frame: Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
PFS per RECIST 1.1. PFS is defined as time from Day 1 of maintenance therapy to disease progression or death.
Time frame: Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Concentration of quaratusugene ozeplasmid in whole blood samples.
Time frame: First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Number of months from Day 1 of maintenance therapy to the date of death.
Time frame: Approximately 18 months
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Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
RECRUITINGGabrail Cancer Center Research
Canton, Ohio, United States
RECRUITINGOncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
RECRUITINGOncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
RECRUITINGOncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
RECRUITINGOncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
RECRUITINGOncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States
RECRUITINGWillamette Valley Cancer Institute (Oregon)
Eugene, Oregon, United States
RECRUITINGNorthwest Cancer Specialists, P.C.
Portland, Oregon, United States
RECRUITING...and 7 more locations