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AGEN1777

Phase 1

Advanced Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Oct 15, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05025085A Study Investigating AGEN1777 in Participants With Advanced Solid TumorsPHASE1 COMPLETED 25Oct 4, 2021Apr 1, 2024Oct 15, 202511 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to 2 years and 90 days
Secondary Endpoints
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination
Day 1 Up to End of Treatment (up to 2 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy with AGEN1777EXPERIMENTAL3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]).
AGEN1777 in combination with a PD-1 inhibitorEXPERIMENTAL3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.
Interventions
NameTypeDescription
AGEN1777DRUGAn immunoglobulin gamma (IgG1) antibody
a PD-1 inhibitorDRUGAnti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies. 2. Measurable disease on baseline imaging based on Response Evaluation Criter...

Countries:United States
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