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Olvi-Vec · 2 trials · 4 indications
Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0
Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer.
To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate. |
| Phase 1b - Cohort 1 | EXPERIMENTAL | Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu. |
| Phase 1b - Cohort 2 | EXPERIMENTAL | Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu. |
| Phase 1b - Cohort 3 | EXPERIMENTAL | Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu. |
| Phase 2 | EXPERIMENTAL | Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab. |
| Name | Type | Description |
|---|---|---|
| Olvi-Vec | DRUG | Olvi-Vec will be administered to patient for 3 days during C1 |
| platinum (cisplatin or carboplatin) | DRUG | After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum （Carboplatin or Cisplatin）will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred. |
| Etoposide | DRUG | After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred. |
| Platinum-doublet with or without bevacizumab | DRUG | Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab. |
Inclusion Criteria: * Able to understand and voluntarily sign an informed consent form. * Age ≥ 18 years old, gender not limited. * Small cell lung cancer confirmed by organization or cytology. * After receiving platinum based chemotherapy regimens and/or immunotherapy, platinum based chemotherapy ...
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Olvi-Vec is an investigational oncolytic immunotherapy being studied for ovarian cancer, peritoneal carcinomatosis, fallopian tube cancer, and extensive stage small cell lung cancer (SCLC). It is in Phase 1 clinical development and has not been approved by the FDA.
Olvi-Vec is a gene therapy-based oncolytic immunotherapy. It is designed to selectively replicate in and destroy cancer cells while stimulating an immune response. The specific molecular target is not disclosed in available information.
Olvi-Vec is being developed by Genelux Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol GNLX.
Olvi-Vec is currently in Phase 1 clinical trials. It has received Fast Track designation from the FDA for its development program. The drug is investigational and has not yet been approved for any indication.
Olvi-Vec has been studied in two Phase 1 trials. NCT02759588, a completed trial in patients with recurrent or refractory ovarian cancer, enrolled 46 participants in the United States. NCT07136285, an ongoing recruiting trial in China, is studying Olvi-Vec combined with platinum plus etoposide in extensive stage SCLC.
Olvi-Vec is also known by its gene therapy classification as an oncolytic vaccinia virus. No alternative brand names or aliases have been disclosed in the available information.