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XmAb23104

Phase 1

Melanoma (Excluding Uveal Melanoma) | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Jul 5, 2024

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03752398A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)PHASE1 COMPLETED 198May 1, 2019Feb 15, 2024Jul 5, 202418 United States
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Study Endpoints
Primary Endpoints
Treatment-related adverse events as assessed by CTCAE v4.03
56 Days

Safety and tolerability

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XmAb®23104 MonotherapyEXPERIMENTALXmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
XmAb®23104 Combination Therapy with IpilimumabEXPERIMENTALXmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)
Interventions
NameTypeDescription
XmAb®23104BIOLOGICALMonoclonal bispecific antibody
Yervoy® (ipilimumab)BIOLOGICALMonoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following: Histologically or cytologically confirmed advanced solid tumors, including the following: 1. Melanoma (excluding uveal melanoma) 2. Cervical carcinoma 3. Pancreatic carcinoma 4...

Countries:United States
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