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NCT05141149 · ClinicalTrials.gov registry record · Phase 1
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
A Phase 1 study of Pancreatic Cancer, sponsored by Prestige Biopharma Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT05141149: Recruiting Phase 1 study of Pancreatic Cancer, sponsored by Prestige Biopharma Limited.
NCT05141149 is a Phase 1 study of Pancreatic Cancer that is actively recruiting participants, run by Prestige Biopharma Limited. The registered enrollment target is 80 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05141149, a Phase 1 study of Pancreatic Cancer, is actively recruiting participants, sponsored by Prestige Biopharma Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG PBP1510 (400mg/16mL)
- DRUG Gemcitabine (1000 mg/m^2)
Study Locations (4)
Other
- Monash Health - Melbourne
- National Cancer Centre Singapore - Singapore
New York
- Northwell Health / R.J. Zuckerberg Cancer Center - New Hyde Park
Madrid
- Hospital Universitario La Paz - Madrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05141149 shows while recruiting
NCT05141149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which PBP1510 (400mg/16mL) is the first listed.
NCT05141149 reports a single indexed study location in Other, New York, Madrid.
Frequently Asked Questions
What is clinical trial NCT05141149 about?
NCT05141149 is a clinical study titled "First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer". 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-...
What is the current status of trial NCT05141149?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2023-06-05. Estimated completion is 2026-12.
What conditions does trial NCT05141149 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT05141149?
The interventions under investigation include: PBP1510 (400mg/16mL) (DRUG), Gemcitabine (1000 mg/m^2) (DRUG).
Who is sponsoring clinical trial NCT05141149?
This trial is sponsored by Prestige Biopharma Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05141149 being conducted?
This trial has 4 study locations across New York, Madrid. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05141149's enrollment target sits among peer trials
80 120th of 278 higher than 155 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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