Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05632328 | AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC | PHASE2 | ACTIVE NOT_RECRUITING | 24 | — | — | Aug 8, 2024 | Apr 1, 2027 | Apr 20, 2026 | 1 | United States |
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
| Arm | Type | Description |
|---|---|---|
| COHORT 1: AGEN1423 Plus Botensilimab | EXPERIMENTAL | Treatment 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 Chemotherapy | EXPERIMENTAL | Treatment 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. |
| Name | Type | Description |
|---|---|---|
| AGEN1423 | DRUG | via IV, dosage per protocol, once every 2 weeks for up to 8 weeks |
| Botensilimab | DRUG | via IV, dosage per protocol, once evert 2 weeks, up to 2 years |
| Gemcitabine | DRUG | per standard care |
| Nab-paclitaxel | DRUG | per standard care |
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...