Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PBP1510 · 1 trial · 1 indication
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 ...
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PBP1510 is an investigational small molecule being developed for the treatment of pancreatic cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with pancreatic cancer to evaluate its safety, tolerability, and preliminary efficacy.
PBP1510 is an anti-PAUF monoclonal antibody, meaning it targets the PAUF (Pancreatic Adenocarcinoma Upregulated Factor) protein. PAUF is a protein that is overexpressed in pancreatic cancer and is believed to play a role in tumor growth and metastasis. By targeting PAUF, PBP1510 aims to inhibit the progression of pancreatic cancer.
PBP1510 is being developed by Prestige Consumer Healthcare Inc., a company publicly traded under the ticker symbol PBH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pancreatic cancer.
PBP1510 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or any other regulatory authority. The ongoing Phase 1/2a trial is the first human study of PBP1510, designed to assess its safety, tolerability, and preliminary efficacy in patients with pancreatic cancer.
PBP1510 is being studied in a single clinical trial with the identifier NCT05141149. This is a First in Human Phase 1/2a trial of the anti-PAUF monoclonal antibody PBP1510 in patients with pancreatic cancer. The trial is currently recruiting participants and aims to enroll 80 patients across the United States, Australia, Singapore, and Spain.
Yes, PBP1510 is also known as PBP1510 (400mg/16mL), which refers to a specific formulation or dosage strength of the drug. The alternative name is used to describe the concentration of the drug in a particular presentation, but it refers to the same investigational compound being developed for pancreatic cancer.