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Olvi-Vec

Phase 1

SCLC, Extensive Stage | Small molecule | Other |Genelux Corporation|Last Updated: Dec 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07136285Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLCPHASE1 RECRUITING 27Jul 24, 2023Dec 1, 2026Dec 3, 20252 China
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Study Endpoints
Primary Endpoints
Evaluate safety of Olvi-Vec in patients from day 1 to end of study
Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0

Secondary Endpoints
Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1
Day 1 to day 25 of treatment cycle 1
Objective Response Rate (ORR)
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)
Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ExperimentalEXPERIMENTALOlvi-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.
Interventions
NameTypeDescription
Olvi-VecDRUGOlvi-Vec will be administered to patient for 3 days during C1
platinum (cisplatin or carboplatin)DRUGAfter 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.
EtoposideDRUGAfter 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 ...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07136285primaryCompletionDate: changed
LOWMay 24, 2026NCT07136285studyFirstPostDate: changed