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Ixovex-1

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |IQVIA Holdings, Inc.|Last Updated: Jan 30, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Ixovex-1 · 1 trial · 2 indications

Phase 1 1
NCT06549946Ixovex-1 Single Agent and Combination TherapySolid Tumor
RECRUITING18 Analytics
PHASE1RECRUITING
Ixovex-1 Single Agent and Combination Therapy
Solid TumorUnlock trial analytics

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 to 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 (matched to "Solid Tumor")

Frequently asked questions about Ixovex-1

What is Ixovex-1 used for in solid tumors?

Ixovex-1 is an investigational monoclonal antibody being developed for the treatment of solid tumors, including head and neck cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does Ixovex-1 target?

Ixovex-1 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied in a Phase 1 trial for solid tumors, including head and neck cancer, with biomarker-selected patients.

Who is developing Ixovex-1?

Ixovex-1 is being developed by IQVIA Holdings, Inc., a company traded on the New York Stock Exchange under the ticker symbol IQV. The drug is currently in Phase 1 clinical development for solid tumors.

What phase is Ixovex-1 in?

Ixovex-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants.

What clinical trials is Ixovex-1 in?

Ixovex-1 is being studied in a Phase 1 clinical trial with the identifier NCT06549946, titled 'Ixovex-1 Single Agent and Combination Therapy.' The trial is recruiting participants in the United Kingdom and is expected to enroll 18 patients with solid tumors, including head and neck cancer.

Is Ixovex-1 the same as any other drug?

No alternative names for Ixovex-1 have been disclosed. The drug is known only by its development name, Ixovex-1, and is being studied under the clinical trial identifier NCT06549946.