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2023-06-05
2026-02
2026-12
80
NCT05141149
Prestige Biopharma Limited
Prestige Biopharma Limited
INTERVENTIONAL
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-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.
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 on the analysis of the PK, safety, and efficacy data. Part 2 (Phase 2a) will be an open-label study and patients will be administered the RP2D of PBP1510 derived from Part 1, in combination with gemcitabine for advanced/metastatic pancreatic cancer patients whose tumour has progressed on one previous line of chemotherapy for locally advanced/metastatic disease.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-08-27 | N/A | 2025-05-31 |
2021-11-18 | N/A | 2025-06-04 |
2021-12-02 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cohort 1M 1 mg/kg of PBP1510 as monotherapy will be administered | DRUG: PBP1510 (400mg/16mL)
|
| EXPERIMENTAL: Cohort 1C 1 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered | DRUG: PBP1510 (400mg/16mL)
DRUG: Gemcitabine (1000 mg/m^2)
|
| EXPERIMENTAL: Cohort 2M 3 mg/kg of PBP1510 as monotherapy will be administered | DRUG: PBP1510 (400mg/16mL)
|
| EXPERIMENTAL: Cohort 2C 3 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered | DRUG: PBP1510 (400mg/16mL)
DRUG: Gemcitabine (1000 mg/m^2)
|
| EXPERIMENTAL: Cohort 3M 6 mg/kg of PBP1510 as monotherapy will be administered | DRUG: PBP1510 (400mg/16mL)
|
| EXPERIMENTAL: Cohort 3C 6 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered | DRUG: PBP1510 (400mg/16mL)
DRUG: Gemcitabine (1000 mg/m^2)
|
| EXPERIMENTAL: Cohort 4M 10 mg/kg of PBP1510 as monotherapy will be administered | DRUG: PBP1510 (400mg/16mL)
|
| EXPERIMENTAL: Cohort 4C 10 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered | DRUG: PBP1510 (400mg/16mL)
DRUG: Gemcitabine (1000 mg/m^2)
|
| EXPERIMENTAL: Cohort 5M 15 mg/kg of PBP1510 as monotherapy will be administered | DRUG: PBP1510 (400mg/16mL)
|
| EXPERIMENTAL: Cohort 5C 15 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered | DRUG: PBP1510 (400mg/16mL)
DRUG: Gemcitabine (1000 mg/m^2)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PART 1 (PHASE 1): To evaluate safety and tolerability of PBP1510 | 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. | Baseline to Safety Follow Up visit (90 days after last dose of PBP1510) |
| PART 1 (PHASE 1): Dose limiting toxicity (DLT) evaluation | DLTs will be assessed by the Investigator using the NCI-CTCAE V5.0. | During first treatment cycle (each cycle is 28 days) |
| PART 2 (PHASE 2a): To establish safety of PBP1510 in combination with gemcitabine | As assessed by evaluation of AEs and SAEs. 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. | Baseline to Safety Follow Up visit (90 days after last dose of PBP1510) |
| PART 2 (PHASE 2a): To assess the efficacy of PBP1510 in combination with gemcitabine | As assessed by objective response rate (ORR; rate of patients with complete response [CR] or partial response [PR]) evaluated by Response Evaluation Criteria in Solid Tumours version v1.1 (RECIST v1.1). | Baseline to End of Treatment visit (28 days after last dose of PBP1510) |
| PART 1 (PHASE 1): Determine the recommended Phase 2a dose (R2PD) of PBP1510 | The RP2D will be selected based on the analysis of the PK, safety, and efficacy data. | After last patient enrolled in last dosing cohort completes 4 cycles of treatment. Each cycle is 28 days. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PART 1 (PHASE 1): Peak concentration (Cmax) of PBP1510 (µg/ml) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | Cycle (C) 1 Day (D) 1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Time to reach Cmax (Tmax) of PBP1510 (hr) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Terminal elimination half-life (t1/2) of PBP1510 (hr) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of PBP1510 (hr*µg /ml) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Mean residence time (MRT) of PBP1510 (hr) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Volume of distribution at steady state (Vss) of PBP1510 (mL/kg) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Volume of the central compartment (Vc) of PBP1510 (mL/kg) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Clearance (CL) of PBP1510 (mL/kg/hr) | administered as monotherapy, and in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease | C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 1 (PHASE 1): Peak concentration (Cmax) of gemcitabine (µg/ml) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Time to reach Cmax (Tmax) of gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Terminal elimination half-life (t1/2) of gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of gemcitabine (hr*µg /ml) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Mean residence time (MRT) of gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Clearance (CL) of gemcitabine (mL/kg/hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days. |
| PART 1 (PHASE 1): Presence of anti-drug antibody (ADA) and neutralizing antibodies (NAb) against PBP1510 administered as monotherapy, and in combination with gemcitabine. | following IV administration, in patients with pancreatic cancer whose tumours have progressed after at least one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D15, C2D1, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Trough concentration (Ctrough) of PBP1510 (µg/ml) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Peak concentration (Cmax) of PBP1510 (µg/ml) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Time to reach Cmax (Tmax) of PBP1510 (hr) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Terminal elimination half-life (t1/2) of PBP1510 (hr) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Area under the concentration-time curve (AUC) of PBP1510 (hr*µg /ml) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Mean residence time (MRT) of PBP1510 (hr) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Volume of distribution at steady state (Vss) of PBP1510 (mL/kg) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Volume of the central compartment (Vc) of PBP1510 (mL/kg) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Clearance (CL) of PBP1510 (mL/kg/hr) | administered in combination with gemcitabine, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
| PART 2 (PHASE 2a): Trough concentration (Ctrough) of Gemcitabine (µg/ml) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Peak concentration (Cmax) of Gemcitabine (µg/ml) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Time to reach Cmax (Tmax) of Gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Terminal elimination half-life (t1/2) of Gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Area under the concentration-time curve (AUC) of Gemcitabine (hr*µg /ml) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Mean residence time (MRT) of Gemcitabine (hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Clearance (CL) of Gemcitabine (mL/kg/hr) | administered in combination with PBP1510, following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days. |
| PART 2 (PHASE 2a): Progression-free survival (PFS) after treatment with PBP1510 administered in combination with gemcitabine | in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | From the first PBP1510 infusion to date of first documentation of progressive disease or death from any cause, through study completion (approximately 1 year) |
| PART 2 (PHASE 2a): Overall Survival (OS) after treatment with PBP1510 administered in combination with gemcitabine | in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | From the first PBP1510 infusion to the date of death due to any cause, through study completion (approximately 1 year) |
| PART 2 (PHASE 2a): Duration of Response (DoR) after treatment with PBP1510 administered in combination with gemcitabine | in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | from the first documentation of overall response (CR or PR) post first PBP1510 infusion to the first documentation of disease progression or death from any cause, through study completion (approximately 1 year) |
| PART 2 (PHASE 2a): Presence of ADA and NAb against PBP1510 administered in combination with gemcitabine. | following IV administration, in patients with pancreatic cancer whose tumours have progressed after one previous line of chemotherapy for locally advanced/metastatic disease. | C1D1, C2D1, C3D1, C4D1, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow-up visit (90 days after last dose of PBP1510). Each cycle is 28 days. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Mei Li Lim Phone Number: +65-6924-6535 Email: meili.lim@prestigebio.com |
Study Contact Backup Name: Fang Ting Pan Phone Number: +65-6924-6535 Email: fangting.pan@prestigebio.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
