Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REQORSA
quaratusugene ozeplasmid · 2 trials · 2 indications
The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab. Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).
PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
RP2D, which will be the maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.
ORR (complete response \[CR\]+ partial response \[PR\]) according to RECIST using best overall response.
PFS from randomization to disease progression or death. Response according to RECIST.
| Arm | Type | Description |
|---|---|---|
| Phase 1 | EXPERIMENTAL | Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity. Quaratusugene ozeplasmid doses will be evaluated (0.09 \[starting dose\], and 0.12 mg/kg) until the RP2D is identified. |
| Phase 2 | EXPERIMENTAL | Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous \[SQ\] administration once every 21 days) until disease progression or unacceptable toxicity |
| Investigational | EXPERIMENTAL | In Phase 1, Phase 2a and the investigational arm of Phase 2b, patients will receive their assigned dose of quaratusugene ozeplasmid (intravenous administration once every 21 days) plus osimertinib (80 mg fixed dose oral tablet taken daily starting on Day 1 through Day 21 of every 21-day treatment cycle) until disease progression or unacceptable toxicity. |
| Control | ACTIVE_COMPARATOR | In the control arm of Phase 2b, patients will receive platinum-based chemotherapy until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| quaratusugene ozeplasmid | BIOLOGICAL | Quaratusugene ozeplasmid is an experimental nonviral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells. |
| atezolizumab | BIOLOGICAL | Atezolizumab is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death-receptor 1 ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. |
| osimertinib | DRUG | Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations. |
| Platinum-Based Chemotherapy | DRUG | Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed. |
Inclusion Criteria: * Male or female aged ≥18 years. * Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide * Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after ...
Quaratusugene ozeplasmid is an investigational therapy being studied in lung cancer. It is in Phase 1 clinical development for extensive stage small cell lung cancer and for non-small cell lung carcinoma, specifically in patients whose disease has progressed on osimertinib. It is not approved for any indication.
Quaratusugene ozeplasmid is a gene therapy. Its target class is described as -vec/-gene, meaning it delivers genetic material rather than acting through a conventional small molecule or antibody mechanism. It is being developed in oncology, where the goal is to introduce therapeutic genes into tumor cells.
Quaratusugene ozeplasmid is being developed by Genprex, Inc., which trades under the ticker GNPX. Genprex is the sponsor of the clinical programs evaluating the agent in lung cancer, including the Phase 1 studies in extensive stage small cell lung cancer and non-small cell lung carcinoma.
Quaratusugene ozeplasmid is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program includes studies in extensive stage small cell lung cancer and in non-small cell lung carcinoma that has progressed on osimertinib.
Quaratusugene ozeplasmid is being studied in two recruiting Phase 1 trials. NCT05703971 evaluates quaratusugene ozeplasmid with atezolizumab maintenance therapy in extensive stage small cell lung cancer. NCT04486833 evaluates quaratusugene ozeplasmid with osimertinib in advanced non-small cell lung cancer that progressed on osimertinib. Both are active in the United States.
Yes. Quaratusugene ozeplasmid is also known as Reqorsa. The two names refer to the same investigational gene therapy developed by Genprex, Inc. Clinical trial listings use both names, including the Phase 1 studies in extensive stage small cell lung cancer and non-small cell lung carcinoma.