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Ixovex-1

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |IQVIA Holdings, Inc.|Last Updated: Jan 30, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06549946Ixovex-1 Single Agent and Combination TherapyPHASE1 RECRUITING 18 — — Dec 17, 2024Jan 30, 2027Jan 30, 20251 United Kingdom
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Study Endpoints
Primary Endpoints
To determine the safety profile of Ixovex-1 when administered by intratumoural injection alone or in combination with Pembrolizumab in patients with unresectable, locally advanced, or metastatic solid tumours.
Through study completion, an average of 2 years

Percentage of subjects with DLTs during the DLT period \[Day 1 to Day 28\]. Percentage of subjects with SAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\]. Percentage of subjects with TEAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\].

To determine the MTD and recommended Phase 2 dose of Ixovex-1.
Through study completion, an average of 2 years

Percentage of subjects with TEAEs, overall and by maximum severity \[Day 1 to 30 days after last dose\].

Secondary Endpoints
To assess clinical efficacy using a combination of radiological imaging, medical photography, and histology.
Through study completion, an average of 2 years
Assessment of antitumour effects in injected tumours and in non-injected tumours.
Through study completion, an average of 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase IaEXPERIMENTALIn Phase Ia, subjects will receive Ixovex-1 intratumourally.
Phase IbEXPERIMENTALIn Phase Ib, subjects will receive combination therapy with Ixovex-1 intratumourally and Pembrolizumab at the standard dose.
Phase IIEXPERIMENTALIn Phase II, subjects will receive combination therapy with Ixovex-1 intratumourally and Pembrolizumab at the standard dose.
Interventions
NameTypeDescription
Ixovex-1BIOLOGICALIxovex-1 is a novel oncolytic human adenovirus serotype 5.
PembrolizumabBIOLOGICALHumanised antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Have signed an informed consent indicating that the subject is aware of the neoplastic nature of their d...

Countries:United Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06549946studyFirstPostDate: changed