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ganitumab

Phase 1

Lymphoma | Monoclonal antibody | Oncology |Amgen Inc.|Last Updated: Jul 18, 2013

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00562380AMG-479 in Treating Patients With Advanced Solid Tumors or Non-Hodgkin LymphomaPHASE1 COMPLETED 64 — — Oct 1, 2005Jun 1, 2010Jul 18, 20131 United States
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Study Endpoints
Primary Endpoints
Safety
Pharmacokinetic profile
Secondary Endpoints
Level of insulin-like growth factor receptor-1 (IGF-1R) on peripheral blood cells
Tumor response measured by modified RECIST
Tumor glucose metabolism as measured by fludeoxyglucose F 18-PET/CT scan
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
ganitumabBIOLOGICAL -
laboratory biomarker analysisOTHER -
pharmacological studyOTHER -
biopsyPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed advanced solid tumors or non-Hodgkin lymphoma that is refractory to standard treatment or for which no curative therapy is available * Tumor tissue that is accessible for biopsy by using minimally invasive pro...

Countries:United States
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Competitive Landscape -Lymphoma 345 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY13PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Ibrutinib
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AstraZeneca PLCAZN15PHASE3Surovatamig, R-CHOP, R-CVP, BR, AZD0486
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles., Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy, CTL019
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide, tafasitamab, rituximab, lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Zanubrutinib, Bendamustine, Rituximab, Venetoclax, Tislelizumab
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax, Loncastuximab Tesirine and Epcoritamab, Venetoclax; Rituximab, DRC, Obinutuzumab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine
Bristol-Myers Squibb CompanyBMY18PHASE3Azacitidine, Romidepsin, Gemcitabine, Golcadomide, Rituximab
Johnson & JohnsonJNJ11PHASE3Ibrutinib, Ibrutinib / Bortezomib / Rituximab, Venetoclax, JNJ-90009530, JNJ-80948543
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide, Gemcitabine, Dexamethasone
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin, Cyclophosphamide
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate, CPI-818
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx, HMPL-760 planned dose 1
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK8PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone, TAK-007
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