Recent Updates
Recently added Catalysts

AGEN2373

Phase 1

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

AGEN2373 development status

Highest phase Phase 1
Registered trials 3 across 2 sponsors since Oct 2019

AGEN2373 target and mechanism

ModalitySmall molecule

Also known as Anti-CD137

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

AGEN2373 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Cancer 7 trials (matched to "Advanced Cancer")

Unlock Competitive Intelligence

Frequently asked questions about AGEN2373

What is AGEN2373?

AGEN2373 is an investigational small molecule therapeutic being developed by Agenus Inc. for the treatment of advanced cancer. It is in Phase 1 clinical development and has been studied in a single completed trial that enrolled 91 patients. It is not approved for any indication.

What is AGEN2373 used for in advanced cancer?

AGEN2373 is being studied for use in patients with advanced cancer. Its only clinical trial to date, NCT04121676, enrolled 91 adults with advanced cancer in the United States. The trial is completed, and the drug remains investigational rather than approved for routine clinical use.

Who makes AGEN2373?

AGEN2373 is made by Agenus Inc., a biopharmaceutical company that trades under the ticker AGEN. Agenus is the developer responsible for the clinical program evaluating AGEN2373 in advanced cancer.

What phase is AGEN2373 in?

AGEN2373 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT04121676, which enrolled 91 patients with advanced cancer. There are currently no active trials listed for AGEN2373, and it is not FDA approved.

What clinical trials is AGEN2373 in?

AGEN2373 has been evaluated in one clinical trial, NCT04121676, titled Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer. The Phase 1 trial enrolled 91 adults with advanced cancer in the United States and is now completed.