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| Name | Class |
|---|---|
| Genelux Corporation | INDUSTRY |
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Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC
Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olvi-Vec | Drug | Olvi-Vec will be administered to patient for 3 days during C1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of Olvi-Vec in patients from day 1 to end of study | Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0 | Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1 | Olvi-Vec related Grade 3 or higher adverse events (AEs) which meets DLT criteria. | Day 1 to day 25 of treatment cycle 1 |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Chen | Contact | +8613801955339 | hannah.chen@newsoara.com | |
| Helena zhu | Contact | helena.zhu@newsoara.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D010984 | Platinum |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| 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. |
|
ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.
| Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years. |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1 | Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years. |
| Progression free survival (PFS) | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first) | Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years. |
| Shanghai chest hospital | Recruiting | Shanghai | China |
|
| D008670 |
| Metals |
| D017606 | Chlorine Compounds |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |