First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Prestige Biopharma Limited
Study ID
NCT05141149
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 5, 2023
Status verified
May 2025
Primary completion
Feb 28, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1M
    1 mg/kg of PBP1510 as monotherapy will be administered
  • Experimental: Cohort 1C
    1 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
  • Experimental: Cohort 2M
    3 mg/kg of PBP1510 as monotherapy will be administered
  • Experimental: Cohort 2C
    3 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
  • Experimental: Cohort 3M
    6 mg/kg of PBP1510 as monotherapy will be administered
  • Experimental: Cohort 3C
    6 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
  • Experimental: Cohort 4M
    10 mg/kg of PBP1510 as monotherapy will be administered
  • Experimental: Cohort 4C
    10 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered
  • Experimental: Cohort 5M
    15 mg/kg of PBP1510 as monotherapy will be administered
  • Experimental: Cohort 5C
    15 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Primary Outcome Measure

PART 1 (PHASE 1): To evaluate safety and tolerability of PBP1510 [ Time Frame: Baseline to Safety Follow Up visit (90 days after last dose of PBP1510) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health / R.J. Zuckerberg Cancer CenterNew Hyde ParkNew York11042
Jenna Battaglia
[email protected]
Daniel A King, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Hyde Park, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Northwell Health / R.J. Zuckerberg Cancer Center· New Hyde Park, NY

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