Recent Updates
Recently added Catalysts

MDX 1411

Phase 1

Kidney Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: May 14, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00656734Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.PHASE1 COMPLETED 27Apr 1, 2008Jun 1, 2010May 14, 20137 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Determine the safety profile of MDX 1411
duration of study
Determine the maximum tolerated dose of MDX 1411
duration of study
Secondary Endpoints
Determine the best overall response rate (BORR)
Day 38-42 of each cycle
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MDX 1411EXPERIMENTALDose Escalation Cohorts
Interventions
NameTypeDescription
MDX 1411BIOLOGICALMDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically confirmed diagnosis of RCC with clear cell component * Measurable disease * Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy * Subjects with treated brain metastases must be without magn...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Kidney Cancer 114 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3Nivolumab and rHuPH20, Nivolumab, Ipilimumab, Cabozantinib, Sunitinib
Merck & Co., Inc.MRK19PHASE3Pembrolizumab, Belzutifan, Lenvatinib, Everolimus, Cabozantinib
AstraZeneca PLCAZN8PHASE3Savolitinib, Sunitinib, Volrustomig, Casdatifan, Nivolumab
Exelixis, Inc.EXEL8PHASE3XL092, Nivolumab, Sunitinib, Cabozantinib, Ipilimumab
Arcus Biosciences, Inc.RCUS3PHASE3Casdatifan, Cabozantinib, AB598, Zimberelimab, Fluorouracil
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE389Zr-TLX250 PET/CT, 177Lu-TLX250 and Peposertib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Fianlimab, Ipilimumab, Nivolumab, Cemiplimab, Pexastimogene Devacirepvec
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2/PHASE3fruquintinib+sintilimab, axitinib / everolimus
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Actuate Therapeutics, Inc.ACTU1PHASE29-ING-41, Gemcitabine - 21 day cycle, Doxorubicin., Lomustine, Carboplatin.
Apollomics Inc. Class AAPLM1PHASE2APL-101
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Syndax Pharmaceuticals IncSNDX1PHASE2Entinostat, Interleukin-2
Pfizer Inc.PFE1PHASE1PF-08634404, Ipilimumab, Axitinib
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Rein Therapeutics, IncRNTX1PHASE3Nivolumab, Ipilimumab, Pembrolizumab, Cabozantinib, Axitinib
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
Psyence Biomedical Ltd.PBM1PHASE2Psilocybin therapy
Janux Therapeutics, Inc.JANX1PHASE1JANX008
Kura Oncology, Inc.KURA1PHASE1Darlifarnib, Cabozantinib, Adagrasib
Unlock Competitive Intelligence