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Odronextamab multiple dose levels

Phase 1

Non-Hodgkin Lymphoma | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Oct 10, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02290951Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell MalignanciesPHASE1 COMPLETED 200Jan 9, 2015Aug 21, 2025Oct 10, 202522 United States, France +3
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Study Endpoints
Primary Endpoints
Safety/overall frequency of adverse events (AEs)
Up to 24 months

Part A and B

Safety/dose limiting toxicities (DLTs)
Up to 28 days

Part A and B

Antitumor activity as measured by the objective response rate (ORR)
Through study completion, an average of 24 months

Expansion Cohorts: • Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy Part A

Secondary Endpoints
Pharmacokinetics (Concentration of odronextamab)
Up to 10 months
Incidence of anti-drug antibodies (ADA) to odronextamab
Over time; up to approximately 15 months
Titer of ADA to odronextamab
Over time; up to approximately 15 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part AEXPERIMENTALDLBCL post CAR-T
1N Part BEXPERIMENTALFL
2N Part BEXPERIMENTALDLBCL
Interventions
NameTypeDescription
Odronextamab multiple dose levelsDRUGAdministered by intravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Key Inclusion Criteria: 1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate: * Part A (IV administration) B-NHL confirmed by National Ca...

Countries:United StatesFranceGermanyIsraelUnited Kingdom
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