Recent Updates
Recently added Catalysts

XB371

Phase 1

Solid Tumors | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Feb 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07123103A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 150 — — Aug 18, 2025Feb 1, 2028Feb 17, 20269 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants with a Dose-limiting Toxicity (DLT)
Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Up to approximately 7 months
Secondary Endpoints
Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose-escalation CohortsEXPERIMENTALParticipants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
Dose-expansion Cohorts: Part AEXPERIMENTALParticipants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \[RD\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
Dose-expansion Cohorts: Part BEXPERIMENTALParticipants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
Interventions
NameTypeDescription
XB371DRUGIntravenous (IV) infusion.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of ≥ 12 weeks. * Recurrent locally advanced or metastatic solid tumors. * Adequate end organ and bone marrow function. Key Exclusion Criteria: * Primary brain tumors or know...

Countries:United States
Unlock Eligibility Criteria
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
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07123103primaryCompletionDate: changed
LOWMay 24, 2026NCT07123103studyFirstPostDate: changed