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AGEN1423

Phase 2

Advanced Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Agenus Inc.|Last Updated: Jul 9, 2026

Target and mechanism

Molecular targetCTLA-4
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AGEN1423 · 1 trial · 3 indications

Phase 2 1
NCT05632328AGEN1423 and Botensilimab w/ or w/o Chemo in PDACAdvanced Pancreatic Ductal Adenocarcinoma
ACTIVE NOT_RECRUITING24 Analytics
PHASE2ACTIVE NOT_RECRUITING
AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC
Advanced Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate
Every 8 weeks until EOT, for up to 2 years.

The objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria, using the modified intent-to-treat (mITT) analysis set

Secondary Endpoints

Disease Control Rate
Every 8 weeks from first day of treatment until EOT for both cohorts up to 2 years.
Median Duration of Overall Response (DOR)
Up to approximately 2 years
Median Overall Survival (OS)
Up to 2 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COHORT 1: AGEN1423 Plus BotensilimabEXPERIMENTALTreatment is AGEN1423 plus Botensilimab for 4 cycles (8 weeks) followed by Botensilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered every 2 weeks.
COHORT 2: AGEN1423 Plus Botensilimab and ChemotherapyEXPERIMENTALTreatment is AGEN1423 plus Botensilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by Botensilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered once every 2 weeks.

Interventions

NameTypeDescription
AGEN1423DRUGvia IV, dosage per protocol, once every 2 weeks for up to 8 weeks
BotensilimabDRUGvia IV, dosage per protocol, once evert 2 weeks, up to 2 years
GemcitabineDRUGper standard care
Nab-paclitaxelDRUGper standard care
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 year and older * Ability to understand and willingness to sign a written informed consent prior to entering the study. * Histologically or cytologically confirmed (either previously or newly biopsied) metastatic or locally advanced unresectable pancreatic adenocarcinoma, in...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJul 9, 2026NCT05632328primaryCompletionDate: changed
MEDIUMJul 9, 2026NCT05632328primaryCompletionDate: changed

Frequently asked questions about AGEN1423

What is AGEN1423 used for in Advanced Pancreatic Ductal Adenocarcinoma?

AGEN1423 is an investigational small molecule being studied for the treatment of Advanced Pancreatic Ductal Adenocarcinoma (PDAC). It is currently in Phase 2 clinical development, evaluated in combination with botensilimab, with or without chemotherapy, in patients with this condition.

What does AGEN1423 target?

AGEN1423 targets CTLA-4, a protein involved in regulating immune responses. By targeting CTLA-4, AGEN1423 is designed to modulate the immune system's activity against cancer cells. This mechanism is being investigated in the context of advanced pancreatic ductal adenocarcinoma.

Who makes AGEN1423?

AGEN1423 is being developed by Agenus Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AGEN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with advanced pancreatic ductal adenocarcinoma.

What phase is AGEN1423 in?

AGEN1423 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 2 trial is actively enrolling participants to assess the drug's effects in advanced pancreatic ductal adenocarcinoma.

What clinical trials is AGEN1423 in?

AGEN1423 is being studied in a Phase 2 clinical trial with the identifier NCT05632328. This trial, titled 'AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC', is active but not recruiting, with an enrollment of 24 participants in the United States.

Is AGEN1423 the same as botensilimab?

No, AGEN1423 is not the same as botensilimab. AGEN1423 is a small molecule targeting CTLA-4, while botensilimab is a separate investigational agent. In the clinical trial NCT05632328, AGEN1423 is being studied in combination with botensilimab, with or without chemotherapy, for advanced pancreatic ductal adenocarcinoma.