Recent Updates
Recently added Catalysts

AGEN1423

Phase 2

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

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
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
Unlock Study Endpoints
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
Unlock Study Design Details
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
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMJul 9, 2026NCT05632328primaryCompletionDate: changed
MEDIUMJul 9, 2026NCT05632328primaryCompletionDate: changed
LOWMay 26, 2026NCT05632328primaryCompletionDate: changed
LOWMay 24, 2026NCT05632328studyFirstPostDate: changed