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OncoMatch/Clinical Trials/NCT05141149

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

Is NCT05141149 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including PBP1510 (400mg/16mL) and Gemcitabine (1000 mg/m^2) for pancreatic cancer.

Phase 1/2RecruitingPrestige Biopharma LimitedNCT05141149Data as of Jun 2026Location: International · 4 countries

Treatment: PBP1510 (400mg/16mL) · Gemcitabine (1000 mg/m^2)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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Gemcitabine (1000 mg/m^2)

Other

PBP1510 (400mg/16mL)

Cancer type

Pancreatic Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard chemotherapy

advanced/metastatic pancreatic cancer patients whose tumours have progressed after at least one prior line of standard chemotherapy

Cannot have received: radiation therapy

Exception: allowed if to < 25% of bone marrow and completed at least 4 weeks before first dose

Patients currently receiving radiation therapy or those having received radiation within 4 weeks prior to study entry

Cannot have received: investigational anti-cancer drug

Patients having received investigational anti-cancer drug within 28 days (or 5 half-lives, whichever is longer) preceding the first dose of PBP1510

Cannot have received: chemotherapy

chemotherapy within the last 4 weeks prior to the first dose of PBP1510

Lab requirements

Blood counts

anc ≥ 1.5 × 10^9 /l; haemoglobin ≥ 9 g/dl; platelets ≥ 100 × 10^9 /l

Kidney function

serum creatinine or creatinine clearance (as determined by the cockcroft gault formula) or egfr based on mdrd ≤ 1.5 x uln or ≥ 50 ml/min or ≥ 50 ml/min/1.73 m^2

Liver function

total bilirubin ≤ 2 × uln (≤ 3 x uln for patients with biliary stenting and patients with gilbert's syndrome); ast and alt < 3 x uln (≤ 5 x uln for patients with hepatic metastases)

Cardiac function

lvef ≥ 50% by echo or muga; qtc ≤ 470 ms

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Northwell Health / R.J. Zuckerberg Cancer Center · New Hyde Park, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05141149 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy, investigational anti-cancer drug, chemotherapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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