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AGEN2373

Phase 1

Advanced Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Jan 13, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

AGEN2373 · 1 trial · 1 indication

Phase 1 1
NCT04121676Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced CancerAdvanced Cancer
COMPLETED91 Analytics
PHASE1COMPLETED
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics

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 to 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 (matched to "Advanced Cancer")

Frequently asked questions about AGEN2373

What is AGEN2373 used for?

AGEN2373 is an investigational small molecule being developed for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

How does AGEN2373 work?

AGEN2373 is a small molecule that targets CD137 and CTLA-4, as indicated by the clinical trial title. These are immune checkpoint targets involved in regulating T-cell responses, and modulating them is intended to enhance the immune system's ability to fight cancer cells.

Who is developing AGEN2373?

AGEN2373 is being developed by Agenus Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AGEN. Agenus is conducting clinical research to evaluate the drug's potential in treating advanced cancer.

What phase is AGEN2373 in?

AGEN2373 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with advanced cancer.

What clinical trials is AGEN2373 in?

AGEN2373 has been studied in one completed Phase 1 clinical trial with the identifier NCT04121676. The trial, titled 'Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer,' enrolled 91 participants in the United States. The study was controlled but not randomized or double-blinded.

Is AGEN2373 the same as an anti-CD137 and anti-CTLA-4 monoclonal antibody?

AGEN2373 is being studied in a trial that combines anti-CD137 and anti-CTLA-4 monoclonal antibodies, but AGEN2373 itself is described as a small molecule. The trial evaluates the combination of these antibodies in patients with advanced cancer, and AGEN2373 is part of this investigational approach.