Actively Recruiting
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
Led by Prestige Biopharma Limited · Updated on 2025-06-04
80
Participants Needed
4
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older (or legal age of majority) at consent
- Ability to understand and voluntarily sign the consent form
- Performance Status score of 0 or 1 on ECOG scale
- Histological or cytological diagnosis of advanced or metastatic pancreatic cancer
- Life expectancy of at least 3 months
- No other malignancies interfering with the study treatment
- Prior radiation therapy allowed if limited to less than 25% bone marrow and completed at least 4 weeks prior
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function including blood counts, liver enzymes, kidney function, heart function (LVEF ≥ 50%), and QTc ≤ 470 ms
- Female patients of non-childbearing potential must meet criteria confirming postmenopausal status or surgical sterilization
- Female patients of childbearing potential must have negative pregnancy tests before treatment and agree to use effective contraception
- Male patients with partners of childbearing potential must agree to use effective contraception
- Willingness and ability to comply with study visits, treatments, tests, and contraceptive guidelines
- For Part 1: pancreatic cancer progressed after at least one prior standard chemotherapy line
- For Part 2: pancreatic cancer progressed after exactly one prior standard chemotherapy line
You will not qualify if you...
- Known active brain metastases unless treated, stable for at least 3 months, and off steroids
- Major surgery within 4 weeks prior to study treatment start except minor procedures with full recovery
- Active, uncontrolled infections requiring systemic therapy
- Known HIV infection
- Active hepatitis B, hepatitis C, or syphilis infection
- Impaired cardiac function or uncontrolled significant cardiac diseases
- Serious psychiatric disorders affecting safety or data integrity
- Other malignancies within 5 years except treated basal or squamous cell skin cancer
- Participation in another therapeutic clinical trial
- Receiving radiation therapy or radiation within 4 weeks prior to study entry
- Recent investigational anti-cancer drugs or chemotherapy within specified washout periods
- Known allergy or hypersensitivity to PBP1510 components or related antibodies
- Pregnant or breastfeeding
- Unwilling or unable to comply with study procedures
- History of allergic reactions or intolerance to gemcitabine
- Investigator judgment deeming patient ineligible
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Northwell Health / R.J. Zuckerberg Cancer Center
New Hyde Park, New York, United States, 11042
Actively Recruiting
2
Monash Health
Melbourne, Australia
Actively Recruiting
3
National Cancer Centre Singapore
Singapore, Singapore
Actively Recruiting
4
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
M
Mei Li Lim
CONTACT
F
Fang Ting Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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