Reqorsa (Quaratusugene Ozeplasmid) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (Acclaim-1)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    92
  • sponsor
    Genprex, Inc.
Updated on 1 May 2022
platelet count
tyrosine
kinase inhibitor
serum bilirubin level
metastasis
EGFR
brain metastases
cancer chemotherapy
advanced lung cancer
kidney function test
osimertinib
lung carcinoma

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 Phase (Phase 1) and an Expansion Phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of Reqorsa in combination with osimertinib. 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 prospective maximum tolerated dose (MTD) in combination with osimertinib, identified in the Dose Escalation phase will be confirmed in at least 6 patients to obtain additional safety and anti-tumor activity data. This confirmed Reqorsa dose will be the recommended phase 2 dose (RP2D) used in Phase 2.

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 IdentifierNCT04486833
SponsorGenprex, Inc.
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically documented non-small cell lung cancer (NSCLC)
Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery whether or not patient has received prior chemotherapy
EGFR mutation-positive as detected by an FDA-approved test
Achieved clinical response to osimertinib for ≥4 months
Must have radiological progression on or after treatment with osimertinib and can have either asymptomatic disease or symptomatic disease. For Phase 2 only, eligibility for patients with symptomatic disease is restricted to those with limited metastasis (≤5 metastases)
Eastern Cooperative Oncology Arm (ECOG) performance score from 0 to 1
Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must be ≥10 days beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc., and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery
If treated, asymptomatic brain metastases present, must meet ALL criteria listed
No history of seizures in the preceding 6 months
Definitive treatment must be completed ≥21 days
Patients must be off steroids administered because of brain metastases or related symptoms for ≥7 days
Post-treatment imaging must demonstrate stability or regression of the brain metastases
ANC >1500/mm3, platelet count >100,000/mm3 within ≤7 days
Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤7 days
Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and AST and ALT ≤2.5 X upper limit of normal (ULN) within ≤7 days
Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤21 days
If female of childbearing potential, must have negative serum pregnancy test (serum β-hCG) within ≤7 days
Must agree to 2 forms of contraception including 1 highly effective and 1 effective methods during the study period and for 4 months following the last dose of study treatment
If male, must agree to no sperm donation during study treatment and for an additional 4 months following the last dose of study treatment
Must have voluntarily signed an informed consent in accordance with institutional policies

Exclusion Criteria

Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications
Received standard chemotherapy or monoclonal antibodies to treat NSCLC within ≤21 days
Received prior gene therapy
Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which makes them a candidate for treatment with other approved targeted therapies
Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days
Active systemic viral, bacterial, or fungal infection(s) requiring treatment
Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol
History of myocardial infarction or unstable angina within ≤6 months
Known human immunodeficiency virus (HIV) infection or has active hepatitis infection
Female who is pregnant or breastfeeding
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