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VE800

Phase 1

Metastatic Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 27, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04208958Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic CancerPHASE1 COMPLETED 56 — — Jan 23, 2020Feb 23, 2023Oct 27, 202518 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up

Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events

Objective Response Rate (ORR)
18 months (first patient enrolled to last patient visit completed)

Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Endpoints
Duration of Response (DOR)
Up to two years
Best Overall Response
Up to 2 years
Disease Control Rate (DCR)
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VE800 combination treatment with nivolumabEXPERIMENTALSubjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
Interventions
NameTypeDescription
VE800BIOLOGICALVE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under Good Manufacturing Practice (GMP) conditions. These strains were selected for their ability to induce an immune response.
NivolumabDRUGNivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin Oral CapsuleDRUGVancomycin is an antibiotic used to treat or prevent infection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Partial Inclusion Criteria: * Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. * Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1 * ...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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