A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer
Prestige Biopharma Limited
Summary
The first in human clinical study is planned as an open-label, dose-escalation, and dose-expansion, multicentre, two-part, Phase 1/2a study of PBP1510 administered to patients with advanced/metastatic pancreatic cancer. The study will be conducted in two parts, Part 1 as a PBP1510 single agent dose-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.
Description
The first in human clinical study is planned as an open-label, multicentre, two-part, Phase 1/2a study to assess the safety, pharmacokinetics, and efficacy of PBP1510 in patients with advanced/metastatic pancreatic cancer. Part 1 (Phase 1) is a dose-escalation phase, wherein PBP1510 will be administered, as monotherapy (monotherapy cohorts) or in combination with gemcitabine (combination cohorts) in advanced/metastatic pancreatic cancer patients whose tumours have progressed on at least one previous line of chemotherapy for locally advanced/metastatic disease. The RP2D will be selected based o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sign, and date the written consent form prior to any protocol-specific procedures. 3. Performance Status score less than or equal to 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 4. Have histological or cytological evidence of a diagnosis of pancreatic cancer that is advanced a…
Interventions
- DrugPBP1510 (400mg/16mL)
Humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets and neutralizes PAUF, administered as a 90-minute intravenous infusion
- DrugGemcitabine (1000 mg/m^2)
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.
Locations (4)
- Northwell Health / R.J. Zuckerberg Cancer CenterNew Hyde Park, New York
- Monash HealthMelbourne
- National Cancer Centre SingaporeSingapore
- Hospital Universitario La PazMadrid, Madrid