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HCD122

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

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 Enrollment111
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00670592Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior TherapiesPHASE1 COMPLETED 111Mar 1, 2008Feb 1, 2013Dec 17, 202028 United States, Australia +9
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Study Endpoints
Primary Endpoints
Primary endpoints (phase I) - Incidence rate of DLT and AE
2 years
Primary endpoint (phase II) - Response rate
2 years
Secondary Endpoints
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HCD122OTHER -
Interventions
NameTypeDescription
HCD122DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: * Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification * Patients must have progressed after at ...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyHong KongItalySingaporeSouth KoreaUnited Kingdom
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