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    DRUG:

    Reqorsa (quaratusugene ozeplasmid)

    i
    Other names: GPX-001, DOTAP:Chol-TUSC2, DOTAP:cholesterol-TUSC2 liposome complex, CNVN202, INGN 401
    Company:
    Genprex
    Drug class:
    Apoptosis stimulant, Immunomodulator, Gene transference, TUSC2 gene stimulant
    Related drugs:
    6d
    Dose Escalation Trial of the Combination of Osimertinib and Quaratusugene Ozeplasmid Gene Therapy in Patients with Advanced NSCLC. (PubMed, Clin Lung Cancer)
    Among the 12 patients treated with escalating doses of quaratusugene ozeplasmid and standard doses of osimertinib there were 3 patients with prolonged time to progression, including 1 with continuing PR. Quaratusugene ozeplasmid administration was associated with a delayed infusion-related reaction managed with prophylactic steroids, acetaminophen and diphenhydramine. There were no DLTs. The recommended phase II dose of quaratusugene ozeplasmid in combination with osimertinib in patients with NSCLC progressing after osimertinib treatment is 0.12 mg/kg.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • TUSC2 (Tumor Suppressor 2)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • dexamethasone • Reqorsa (quaratusugene ozeplasmid)
    10ms
    Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=5, Terminated, Genprex, Inc. | N=180 --> 5 | Trial completion date: Dec 2025 --> Feb 2025 | Active, not recruiting --> Terminated; Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.
    Enrollment change • Trial completion date • Trial termination
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)
    1year
    Acclaim-1: Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov)
    P1/2, N=158, Recruiting, Genprex, Inc. | Trial completion date: Dec 2027 --> Mar 2029 | Trial primary completion date: Dec 2026 --> Mar 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Reqorsa (quaratusugene ozeplasmid)
    1year
    Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination with Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=180, Active, not recruiting, Genprex, Inc. | Trial completion date: Nov 2028 --> Dec 2025 | Trial primary completion date: Nov 2027 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)
    over1year
    Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=180, Active, not recruiting, Genprex, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)
    almost2years
    Acclaim-3: Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients (clinicaltrials.gov)
    P1/2, N=62, Recruiting, Genprex, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tecentriq (atezolizumab) • Reqorsa (quaratusugene ozeplasmid)
    over2years
    Acclaim-1: Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov)
    P1/2, N=158, Recruiting, Genprex, Inc. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • Reqorsa (quaratusugene ozeplasmid)
    over2years
    Acclaim-2: Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Genprex, Inc. | Trial completion date: May 2026 --> Nov 2028 | Trial primary completion date: May 2025 --> Nov 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)
    3years
    Acclaim-1: Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov)
    P1/2, N=158, Recruiting, Genprex, Inc. | N=92 --> 158 | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Dec 2024 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • Reqorsa (quaratusugene ozeplasmid)
    over3years
    Acclaim-2: Reqorsa (Quaratusugene Ozeplasmid) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Genprex, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)
    almost4years
    Acclaim-1: Reqorsa (Quaratusugene Ozeplasmid) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (clinicaltrials.gov)
    P1/2, N=92, Recruiting, Genprex, Inc. | Trial completion date: Aug 2025 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • Reqorsa (quaratusugene ozeplasmid)
    almost4years
    Acclaim-2: Reqorsa (Quaratusugene Ozeplasmid) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer (clinicaltrials.gov)
    P1/2, N=156, Not yet recruiting, Genprex, Inc. | Trial completion date: Dec 2025 --> May 2026 | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Dec 2023 --> May 2025
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • docetaxel • Cyramza (ramucirumab) • Reqorsa (quaratusugene ozeplasmid)