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XmAb13676

Phase 1

B-cell Non-Hodgkins Lymphoma | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Nov 13, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02924402Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic MalignanciesPHASE1 COMPLETED 154Oct 1, 2016Apr 1, 2024Nov 13, 202423 United States, France +2
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Study Endpoints
Primary Endpoints
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Baseline Day 1 through Day 56
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Non-CLL B Cell Malignancies (Group NHL) Part AEXPERIMENTALXmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
CLL/SLL (Group CLL) Part AEXPERIMENTALXmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Non-CLL B Cell Malignancies (Group NHL) Part BEXPERIMENTALXmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
CLL/SLL (Group CLL) Part BEXPERIMENTALXmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Non-CLL B Cell Malignancies (Group NHL) Part C / ExpansionEXPERIMENTALXmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Non-CLL B Cell Malignancies (Group NHL) Part D / ExpansionEXPERIMENTALXmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Interventions
NameTypeDescription
XmAb13676BIOLOGICALBiological
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Able to provide written informed consent * Diagnosis of either Non-CLL B cell malignancy * Ineligible for or have exhausted standard therapeutic options and have relapsed or refractory disease * ECOG performance status 0-2 * Fertile patients must agree to use highly effective ...

Countries:United StatesFranceSouth KoreaUnited Kingdom
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