Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486833
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2020-07-22
Brief Title:
Quaratusugene Ozeplasmid Reqorsa and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
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 Osimertinib in Patients With Advanced Metastatic EGFR-Mutant Metastatic Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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-1
Brief Summary:
The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid Reqorsa added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer
The study will comprise of a Phase 1 dose escalation and Phase 2 evaluations of safety and efficacy In the Phase 1 dose escalation patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with osimertinib When the recommended Phase 2 dose RP2D is determined in Phase 1 Phase 2a will be initiated and patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib In Phase 2b patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy
The study will comprise of a Phase 1 dose escalation and Phase 2 evaluations of safety and efficacy In the Phase 1 dose escalation patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with osimertinib When the recommended Phase 2 dose RP2D is determined in Phase 1 Phase 2a will be initiated and patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib In Phase 2b patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy
Detailed Description:
Acclaim-1 is an open-label multi-center Phase 12 study evaluating quaratusugene ozeplasmid Reqorsa plus osimertinib investigational arm versus platinum-based chemotherapy control arm in patients with advanced metastatic or recurrent NSCLC
Toxicities will be assessed by the Investigator using United States National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50 Serious Adverse Events and Dose Limiting Toxicities DLT will be reviewed by a Safety Review Committee
Phase 1 - Dose Escalation The RP2D of quaratusugene ozeplasmid when given in combination with osimertinib will be identified
Phase 2a Once the RP2D of quaratusugene ozeplasmid is identified in Phase 1 an expansion cohort will be enrolled to better characterize safety tolerability and preliminary anti-tumor activity of the combination therapy
Phase 2b Quaratusugene ozeplasmid in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1 Patients may receive local therapy such as radiation therapy to progressing lesions prior to enrollment Patients will be randomized to receive either the investigational arm or the control arm in a 1 to 1 ratio and stratified based on prior local radiotherapy
Toxicities will be assessed by the Investigator using United States National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50 Serious Adverse Events and Dose Limiting Toxicities DLT will be reviewed by a Safety Review Committee
Phase 1 - Dose Escalation The RP2D of quaratusugene ozeplasmid when given in combination with osimertinib will be identified
Phase 2a Once the RP2D of quaratusugene ozeplasmid is identified in Phase 1 an expansion cohort will be enrolled to better characterize safety tolerability and preliminary anti-tumor activity of the combination therapy
Phase 2b Quaratusugene ozeplasmid in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1 Patients may receive local therapy such as radiation therapy to progressing lesions prior to enrollment Patients will be randomized to receive either the investigational arm or the control arm in a 1 to 1 ratio and stratified based on prior local radiotherapy
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?:
None
Is an FDA AA801 Violation?:
None