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ACTR087

Phase 1

Lymphoma | Monoclonal antibody | Oncology |Cogent Biosciences, Inc.|Last Updated: Mar 31, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02776813Study of ACTR087 in Subjects With Relapsed or Refractory B-cell LymphomaPHASE1 COMPLETED 34 — — Aug 1, 2016Feb 12, 2020Mar 31, 20207 United States
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Study Endpoints
Primary Endpoints
Safety as assessed by dose limiting toxicities (DLTs)
28 days
Safety as assessed by determination of the maximum tolerated dose (MTD)
24 months
Safety as assessed by determination of the recommended phase 2 dose (RP2D)
24 months
Safety as assessed by and adverse events, laboratory assessments and physical examinations
24 months
Safety as assessed by mini-mental state examination (MMSE)
24 months
Secondary Endpoints
Overall response rate
24 months
Duration of response
24 months
Progression free survival
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACTR087, in combination with rituximabEXPERIMENTAL -
Interventions
NameTypeDescription
ACTR087BIOLOGICAL -
rituximabBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Signed written informed consent obtained prior to study procedures * Histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: * DLBCL, regard...

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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