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AGEN2373

Phase 1

Advanced Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Jan 13, 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 Enrollment91
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04121676Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced CancerPHASE1 COMPLETED 91 — — Sep 26, 2019Nov 30, 2024Jan 13, 202512 United States
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Study Endpoints
Primary Endpoints
Occurrence of Dose Limiting Toxicity (DLT)
First 28 days of treatment Q2W and Q4W and First 21 days Q3W

DLT in patient in dose escalation phase

Frequency of treatment-emergent adverse events (TEAEs)
Screening to 90 days from last dose

According to NCI-CTCAE Version 5.0, vital signs (blood pressure, heartrate, and temperature), physical examinations, 12-lead electrocardiogram, Eastern Cooperative Oncology Group (ECOG) performance status, and clinical laboratory assessments for all dose groups

Severity of treatment-emergent adverse events (TEAEs)
Screening to 90 days from last dose

According to NCI-CTCAE Version 5.0, vital signs (blood pressure, heartrate, and temperature), physical examinations, 12-lead electrocardiogram, Eastern Cooperative Oncology Group (ECOG) performance status, and clinical laboratory assessments for all dose groups

Duration of treatment-emergent adverse events (TEAEs)
Screening to 90 days from last dose

According to NCI-CTCAE Version 5.0, vital signs (blood pressure, heartrate, and temperature), physical examinations, 12-lead electrocardiogram, Eastern Cooperative Oncology Group (ECOG) performance status, and clinical laboratory assessments for all dose groups

Secondary Endpoints
Maximum observed concentration at steady state (Cmax-ss)
Day 1 of dosing through 90 days from the last dose
Minimum observed concentration at steady state (Cmin-ss)
Day 1 of dosing through 90 days from the last dose
Area under the plasma/serum concentration-time curve within time span t1 to t2 at steady-state (AUC(t1-t2)-ss)
Day 1 of dosing through 90 days from the last dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2-Week Monotherapy with AGEN2373EXPERIMENTAL3+3 Dose escalation of AGEN2373 administered by IV.
3-Week Monotherapy with AGEN2373EXPERIMENTAL3+3 Dose escalation of AGEN2373 administered by IV.
4-Week Monotherapy with AGEN2373EXPERIMENTAL3+3 Dose escalation of AGEN2373 administered by IV.
Combination Therapy with 3-week AGEN2373 Monotherapy Lead-In Combination with 6-week BotensilimabEXPERIMENTAL3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.
Combination Therapy with 3-week AGEN2373 in combination with 6-week BotensilimabEXPERIMENTAL3+3+3 Dose escalation of AGEN2373. AGEN2373 and botensilimab administered by IV.
Interventions
NameTypeDescription
AGEN2373DRUGAn Anti-CD137 Monoclonal Antibody
BotensilimabDRUGAnti-CTLA-4 Monoclonal Antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study specific procedures. Participation in pharmacogenomics testing is optional. 2. ≥ 18 years of age. 3. Histologically or cytologically confirmed diagnosis of a solid tumor ...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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