Reqorsa (Quaratusugene Ozeplasmid) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (Acclaim-1)
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- STATUS
- Recruiting
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- End date
- Dec 11, 2025
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- participants needed
- 92
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- sponsor
- Genprex, Inc.
Summary
The purpose of this randomized study is to determine the safety and efficacy of Reqorsa (quaratusugene ozeplasmid, formerly known as GPX-001) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Reqorsa 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 be conducted in 2 phases, a dose escalation and expansion 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 Reqorsa in combination with osimertinib. When the recommended Phase 2 dose (RP2D) is determined, additional patients will be enrolled in an expansion cohort. In Phase 2, patient will be randomized to receive Reqorsa plus osimertinib or osimertinib alone.
Description
Acclaim-1 is an open-label, multi-center, Phase 1/2 study evaluating Reqorsa (quaratusugene ozeplasmid) plus osimertinib versus monotherapy osimertinib 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 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLT) will be reviewed by a safety review committee.
Phase 1 - Dose Escalation: The RP2D of Reqorsa when given in combination with osimertinib will be identified. Once the RP2D is identified an expansion cohort will be enrolled to better characterize safety, tolerability, and preliminary anti-tumor activity.
Phase 2: Reqorsa 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 combination therapy or osimertinib alone in a 1 to 1 ratio and stratified based on prior local radiotherapy. Other subsets may be explored based on emergent data.
Details
| Condition | Carcinoma, Non-Small Cell Lung |
|---|---|
| Treatment | Osimertinib, Osimertinib Oral Tablet, Quaratusugene ozeplasmid - intravenous infusion, quaratusugene ozeplasmid |
| Clinical Study Identifier | NCT04486833 |
| Sponsor | Genprex, Inc. |
| Last Modified on | 4 October 2022 |
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