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Camidanlumab Tesirine

Phase 2

Relapsed Hodgkin Lymphoma | Small molecule | Oncology |ADC Therapeutics SA|Last Updated: Mar 28, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04052997Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin LymphomaPHASE2 COMPLETED 117Sep 13, 2019Jan 19, 2023Mar 28, 202473 United States, Belgium +9
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR)
Up to 3 years

ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

Secondary Endpoints
Duration of Response (DOR)
Up to 3 years
CR Rate
Up to 3 years
Relapse-Free Survival (RFS)
Up to 3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Camidanlumab TesirineEXPERIMENTALCamidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles.
Interventions
NameTypeDescription
Camidanlumab TesirineDRUGIntravenous Infusion
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites73

Inclusion Criteria: 1. Written informed consent must be obtained prior to any procedures. 2. Male or female participant aged 18 years or older. (16 years or older at US based sites) 3. Pathologic diagnosis of classical Hodgkin lymphoma (cHL). 4. Patients with relapsed or refractory cHL, who have re...

Countries:United StatesBelgiumCanadaCzechiaFranceGermanyHungaryItalyPolandSpainUnited Kingdom
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