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XB628

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Exelixis, Inc.|Last Updated: May 14, 2026

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 Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06952010A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 75 — — May 1, 2025Nov 30, 2027May 14, 202611 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Dose Limiting Toxicities (DLTs)
21 days
Number of Participants with Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and Adverse Events (AEs) Leading to Dose Withholding, Treatment Discontinuation, or Death
27 months
Secondary Endpoints
Area Under the Concentration-time Curve (AUC) of XB628
25 months
Maximum Plasma Concentration (Cmax) of XB628
25 months
Time to Maximum Concentration (Tmax) of XB628
25 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XB628EXPERIMENTALGroup(s) of participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628.
Interventions
NameTypeDescription
XB628BIOLOGICALIntravenous infusion(s)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of ≥ 12 weeks. * Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed. * Adequate organ and marrow function. * Not amenable to cur...

Countries:United States
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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 26, 2026NCT06952010primaryCompletionDate: changed
LOWMay 24, 2026NCT06952010studyFirstPostDate: changed