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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05141149 | First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer | PHASE1 | RECRUITING | 80 | — | — | Jun 5, 2023 | Dec 1, 2026 | Jun 4, 2025 | 4 | United States, Australia +2 |
As assessed by evaluation of adverse events and serious adverse events (AE \& SAE). AEs will be coded using MedDRA and grouped by system organ class and preferred term. An AE which is fatal or life threatening will be considered as SAE.
DLTs will be assessed by the Investigator using the NCI-CTCAE V5.0.
As assessed by evaluation of AEs and SAEs. AEs will be coded using MedDRA and grouped by system organ class and preferred term. An AE which is fatal or life threatening will be considered as SAE.
As assessed by objective response rate (ORR; rate of patients with complete response \[CR\] or partial response \[PR\]) evaluated by Response Evaluation Criteria in Solid Tumours version v1.1 (RECIST v1.1).
The RP2D will be selected based on the analysis of the PK, safety, and efficacy data.
| Arm | Type | Description |
|---|---|---|
| Cohort 1M | EXPERIMENTAL | 1 mg/kg of PBP1510 as monotherapy will be administered |
| Cohort 1C | EXPERIMENTAL | 1 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered |
| Cohort 2M | EXPERIMENTAL | 3 mg/kg of PBP1510 as monotherapy will be administered |
| Cohort 2C | EXPERIMENTAL | 3 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered |
| Cohort 3M | EXPERIMENTAL | 6 mg/kg of PBP1510 as monotherapy will be administered |
| Cohort 3C | EXPERIMENTAL | 6 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered |
| Cohort 4M | EXPERIMENTAL | 10 mg/kg of PBP1510 as monotherapy will be administered |
| Cohort 4C | EXPERIMENTAL | 10 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered |
| Cohort 5M | EXPERIMENTAL | 15 mg/kg of PBP1510 as monotherapy will be administered |
| Cohort 5C | EXPERIMENTAL | 15 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered |
| Name | Type | Description |
|---|---|---|
| PBP1510 (400mg/16mL) | DRUG | Humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets and neutralizes PAUF, administered as a 90-minute intravenous infusion |
| Gemcitabine (1000 mg/m^2) | DRUG | Humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets and neutralizes PAUF, administered as a 90-minute intravenous infusion in combination with 1000 mg/m2 gemcitabine administered as a 30-minute intravenous infusion. |
Inclusion Criteria: Patients enrolling into Part 1 (Phase 1), or Part 2 (Phase 2a) must meet all of the following inclusion criteria: 1. Adults ≥ 18 years of age (or the legal age of majority in the country of recruitment) at the time consent is obtained. 2. Patient should understand, voluntarily ...