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AGEN1571

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Agenus Inc.|Last Updated: Apr 30, 2025

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05377528Study of AGEN1571 in Participants With Advanced Solid TumorsPHASE1 COMPLETED 22 — — Jul 19, 2022Dec 23, 2024Apr 30, 20256 United States
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Study Endpoints
Primary Endpoints
Number Of Participants With Dose-limiting Toxicities
Day 1 through Day 42
Number Of Participants With Treatment-emergent Adverse Events
Day 1 up to 12 months after the last dose
Secondary Endpoints
Serum AGEN1571 Concentration
Day 1 up to 90 days after the last dose
Serum Balstilimab Concentration
Day 1 up to 90 days after the last dose
Serum Botensilimab Concentration
Day 1 up to 90 days after the last dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation: AGEN1571EXPERIMENTALParticipants will receive AGEN1571 monotherapy.
Dose Escalation: AGEN1571 + BalstilimabEXPERIMENTALParticipants will receive AGEN1571 with balstilimab.
Dose Escalation: AGEN1571 + BotensilimabEXPERIMENTALParticipants will receive AGEN1571 with botensilimab.
Dose Escalation: AGEN1571 + Balstilimab + BotensilimabEXPERIMENTALParticipants will receive AGEN1571 with balstilimab and botensilimab.
Dose ExpansionEXPERIMENTALAGEN1571 administered at the RP2D for monotherapy or any combination therapy.
Interventions
NameTypeDescription
AGEN1571DRUGA fully human monoclonal immunoglobulin-like transcript antagonist antibody administered intravenously.
BalstilimabDRUGA fully human monoclonal programmed cell death protein 1 antagonist antibody administered intravenously.
BotensilimabDRUGA fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures (participation in genetic testing is optional). 2. Histologically confirmed diagnosis of a solid tumor that is currently metastatic or locally advance...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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