Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05062980
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-09-20
Brief Title:
Quaratusugene Ozeplasmid Reqorsa in Combination with Pembrolizumab in Previously Treated Non-Small Lung Cancer
Sponsor:
Genprex Inc
Organization:
Genprex Inc
Study Overview
Official Title:
A Phase 12 Open-Label Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination with Pembrolizumab Versus Docetaxel with or Without Ramucirumab in Patients with Previously Treated Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Acclaim-2
Brief Summary:
The purpose of this study is to determine the safety and efficacy of quaratusugene ozeplasmid Reqorsa in combination with pembrolizumab in patients with previously treated NSCLC Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is a systemic gene therapy
The study will be conducted in 2 phases a dose escalation phase Phase 1 and a safety and efficacy evaluation phase Phase 2 In Phase 1 patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose RP2D Phase 2 will be comprised of a dose expansion portion and a randomized portion In the dose expansion portion patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab In the randomized portion patients will be randomized to receive either the investigational treatment of quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab or a control treatment of either docetaxel - ramucirumab or the investigators treatment of choice
The study will be conducted in 2 phases a dose escalation phase Phase 1 and a safety and efficacy evaluation phase Phase 2 In Phase 1 patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose RP2D Phase 2 will be comprised of a dose expansion portion and a randomized portion In the dose expansion portion patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab In the randomized portion patients will be randomized to receive either the investigational treatment of quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab or a control treatment of either docetaxel - ramucirumab or the investigators treatment of choice
Detailed Description:
Acclaim-2 is a Phase 12 multicenter open-label study of quaratusugene ozeplasmid in combination with pembrolizumab in patients with locally advanced or metastatic NSCLC with any PD-L1 TPS and NOT considered refractory to pembrolizumab as defined by having achieved at least a 3-month clinical benefit to previous pembrolizumab-containing treatment
The total duration of study for each patient will be dependent upon the safety tolerability and efficacy of the study treatment
The Phase 1 portion of the study will involve a 33 dose escalation schema of quaratusugene ozeplasmid up to 012 mgkg in combination with a fixed dose of pembrolizumab 200 mg administered once via intravenous IV infusion during each 21-day treatment cycle Three quaratusugene ozeplasmid doses will be tested 006 009 and 012 mgkg administered on Day 1 of a 21-day treatment cycle
Phase 2 will involve a dose expansion portion and a randomized portion In the dose expansion portion 36 patients will be enrolled to better characterize the safety and preliminary efficacy of quaratusugene in combination with pembrolizumab Patients in the dose expansion portion will receive quaratusugene ozeplasmid at the RP2D determined in Phase 1 in combination with pembrolizumab once in every 21-day treatment cycle When the PFS rate at 18 weeks has been evaluated for all patients in the dose expansion portion and been shown to meet the criteria for advancement to the randomized portion of Phase 2 the randomized portion of Phase 2 will be initiated In the randomized portion of Phase 2 126 patients will be randomized 21 to the investigational quaratusugene ozeplasmid in combination with pembrolizumab versus control docetaxel with or without ramucirumab or investigators choice of treatment treatment arms respectively Patients will be stratified by NSCLC histology squamous versus nonsquamous predominant histology for efficacy analysis purposes The 84 patients randomized to the investigational arm will receive quaratusugene ozeplasmid at the RP2D determined in Phase 1 administered in combination with 200 mg pembrolizumab once in every 21-day treatment cycle The 42 patients randomized to the control arm may either receive docetaxel with or without ramucirumab or a non-investigational treatment chosen by the investigator
The total duration of study for each patient will be dependent upon the safety tolerability and efficacy of the study treatment
The Phase 1 portion of the study will involve a 33 dose escalation schema of quaratusugene ozeplasmid up to 012 mgkg in combination with a fixed dose of pembrolizumab 200 mg administered once via intravenous IV infusion during each 21-day treatment cycle Three quaratusugene ozeplasmid doses will be tested 006 009 and 012 mgkg administered on Day 1 of a 21-day treatment cycle
Phase 2 will involve a dose expansion portion and a randomized portion In the dose expansion portion 36 patients will be enrolled to better characterize the safety and preliminary efficacy of quaratusugene in combination with pembrolizumab Patients in the dose expansion portion will receive quaratusugene ozeplasmid at the RP2D determined in Phase 1 in combination with pembrolizumab once in every 21-day treatment cycle When the PFS rate at 18 weeks has been evaluated for all patients in the dose expansion portion and been shown to meet the criteria for advancement to the randomized portion of Phase 2 the randomized portion of Phase 2 will be initiated In the randomized portion of Phase 2 126 patients will be randomized 21 to the investigational quaratusugene ozeplasmid in combination with pembrolizumab versus control docetaxel with or without ramucirumab or investigators choice of treatment treatment arms respectively Patients will be stratified by NSCLC histology squamous versus nonsquamous predominant histology for efficacy analysis purposes The 84 patients randomized to the investigational arm will receive quaratusugene ozeplasmid at the RP2D determined in Phase 1 administered in combination with 200 mg pembrolizumab once in every 21-day treatment cycle The 42 patients randomized to the control arm may either receive docetaxel with or without ramucirumab or a non-investigational treatment chosen by the investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None