Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703971
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-01-19
Brief Title:
Quaratusugene Ozeplasmid Reqorsa and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Sponsor:
Genprex Inc
Organization:
Genprex Inc
Study Overview
Official Title:
A Phase 12 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer ES-SCLC
Status:
RECRUITING
Status Verified Date:
2024-05
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-3
Brief 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 will be conducted in 2 phases a dose selection phase Phase 1 and a safety and efficacy evaluation phase Phase 2
The study will be conducted in 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 12 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 50 Serious Adverse Events and Dose Limiting Toxicities DLTs will be reviewed by a safety review committee
Phase 1 In Phase 1 dose selection patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with atezolizumab The recommended Phase 2 dose RP2D of quaratusugene ozeplasmid when given in combination with atezolizumab will be identified
Phase 2 Quaratusugene ozeplasmid in combination with atezolizumab will be further evaluated using the RP2D identified in Phase 1
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 DLTs will be reviewed by a safety review committee
Phase 1 In Phase 1 dose selection patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with atezolizumab The recommended Phase 2 dose RP2D of quaratusugene ozeplasmid when given in combination with atezolizumab will be identified
Phase 2 Quaratusugene ozeplasmid in combination with atezolizumab will be further evaluated using the RP2D identified in Phase 1
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