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ACTR087

Phase 1

Lymphoma | Monoclonal antibody | Oncology |Cogent Biosciences, Inc.|Trials Updated: Mar 31, 2020

ACTR087 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2016

ACTR087 target and mechanism

Molecular targetBCMA
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

ACTR087 clinical trials

ACTR087 · 1 trial · 1 indication

Phase 1 1
NCT02776813Study of ACTR087 in Subjects With Relapsed or Refractory B-cell LymphomaLymphoma
COMPLETED34 Analytics
PHASE1COMPLETED
Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma
LymphomaUnlock trial analytics

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 to 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 494 trials

Top 20 of 70 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, REGN5837
Merck & Co., Inc.MRK22PHASE3Nemtabrutinib, Zilovertamab vedotin, Pembrolizumab Berahyaluronidase alfa, Pembrolizumab, MK-1045
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, LY4152199, LY4584180
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Surovatamig, AZD0486, AZD4512, AZD5492
Novartis AG Sponsored ADRNVS9PHASE3Tisagenlecleucel, Rapcabtagene autoleucel, PIT565, Tulmimetostat
Incyte CorporationINCY16PHASE3Tafasitamab, parsaclisib, Ruxolitinib
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, KITE-753, KTE-X19, KITE-197, INT2104
AbbVie, Inc.ABBV14PHASE3Venetoclax, Epcoritamab, ABBV-319, ABBV-453, ABBV-525
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab
Johnson & JohnsonJNJ15PHASE3Ibrutinib, Bortezomib, JNJ-90009530, JNJ-80948543, JNJ-75348780
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Tacabrutideg, Zanubrutinib, Lenalidomide, Tislelizumab, Sonrotoclax
Bristol-Myers Squibb CompanyBMY19PHASE3Golcadomide, Lenalidomide, Lisocabtagene maraleucel, Nivolumab, CC-122
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Axitinib, Bosutinib, Crizotinib
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, NX-1607, NX-2127
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
ADC Therapeutics LtdADCT3PHASE3Loncastuximab tesirine
Cellectar Biosciences, Inc.CLRB3PHASE3Iopofosine I-131
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib
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Frequently asked questions about ACTR087

What is ACTR087 used for?

ACTR087 is an investigational monoclonal antibody being studied for the treatment of lymphoma, specifically relapsed or refractory B-cell lymphoma. It is being developed by Cogent Biosciences, Inc. and has been evaluated in a Phase 1 clinical trial. It is not approved for commercial use.

What does ACTR087 target?

ACTR087 targets BCMA, a protein expressed on certain B cells. By binding to BCMA, the antibody is designed to direct immune activity toward B-cell lymphoma cells. BCMA is a protein target, and the drug is classified as a monoclonal antibody in the oncology therapeutic area.

Who is developing ACTR087?

ACTR087 is being developed by Cogent Biosciences, Inc., which trades under the ticker COGT. The company sponsored the Phase 1 study of the antibody in patients with relapsed or refractory B-cell lymphoma in the United States.

What phase is ACTR087 in?

ACTR087 is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 1 trial evaluating ACTR087 in relapsed or refractory B-cell lymphoma has been completed.

What clinical trials is ACTR087 in?

ACTR087 has been evaluated in one clinical trial, NCT02776813, titled Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma. This Phase 1 trial enrolled 34 participants in the United States and is completed. It was an uncontrolled study without randomization or blinding.

Was ACTR087 studied in biomarker-selected patients?

Yes. The Phase 1 trial of ACTR087, NCT02776813, was biomarker selected, meaning participants were chosen based on a specific biological marker. The study enrolled 34 adults aged 18 years and older with relapsed or refractory B-cell lymphoma and was conducted in the United States.