A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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 is comprised of 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: 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.
Arms & interventions
- Biologicalquaratusugene 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.
- Biologicalatezolizumab
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.
Outcome measures
Primary
Maximum 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
Secondary
Safety Profile - Phase 1
Time frame: Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
Time frame: Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Time frame: First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Time frame: Approximately 18 months
Eligibility criteria
Study locations (17)
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Gabrail Cancer Center Research
Canton, Ohio, 44718
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45211
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45236
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45245
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Willamette Valley Cancer Institute (Oregon)
Eugene, Oregon, 97401
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982
Providence Cancer Institute
Portland, Oregon, 97213
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Texas Oncology - DFW
Dallas, Texas, 75246
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684