Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenprex, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
quaratusugene ozeplasmid
Biological/VaccineQuaratusugene 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
Biological/VaccineAtezolizumab 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Phase 1Experimental treatment 2 interventions
Group B: Phase 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 level2
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 therapySecondary outcomes
1
Safety Profile - Phase 1
Adverse events according to CTCAE v5.0
Time frame
Approximately 6 months2
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 months3
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Concentration of quaratusugene ozeplasmid in whole blood samples.
Time frame
First 21-day treatment cycle4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov