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Anti-metabolites

PBP1510 + Gemcitabine for Pancreatic Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Prestige Biopharma Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance Status score less than or equal to 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.

No other malignancy present that would interfere with the current intervention.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first pbp1510 infusion to the date of death due to any cause, through study completion (approximately 1 year)

Awards & highlights

Study Summary

This trial will test a new drug to treat advanced/metastatic pancreatic cancer in two parts: dose-escalation with single and combined agents, then dose-expansion at the recommended dose.

Who is the study for?

Adults over 18 with advanced/metastatic pancreatic cancer, who have had at least one line of standard chemotherapy, can join this trial. They must be in relatively good health (ECOG score ≤1), expect to live more than 3 months, and have no other major illnesses or recent surgeries that could affect the study. Women must not be pregnant and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing PBP1510 alone and combined with gemcitabine in patients with pancreatic cancer. It's a two-part study: first part tests different doses of PBP1510 alone and then with gemcitabine; second part expands the dose found to be safe in combination with gemcitabine.See study design

What are the potential side effects?

Potential side effects for PBP1510 may include allergic reactions due to its components or excipients. Gemcitabine can cause symptoms like fatigue, nausea, skin rash, low blood counts leading to increased infection risk, liver toxicity, and shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my self-care but cannot work.

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I do not have any other cancer that would affect this treatment.

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I am 18 years old or older.

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My pancreatic cancer is advanced or has spread to other parts.

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My pancreatic cancer has worsened after at least one chemotherapy treatment.

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My pancreatic cancer has worsened after one standard chemotherapy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first pbp1510 infusion to the date of death due to any cause, through study completion (approximately 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first pbp1510 infusion to the date of death due to any cause, through study completion (approximately 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first pbp1510 infusion to the date of death due to any cause, through study completion (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PART 1 (PHASE 1): Determine the recommended Phase 2a dose (R2PD) of PBP1510

PART 1 (PHASE 1): Dose limiting toxicity (DLT) evaluation

PART 1 (PHASE 1): To evaluate safety and tolerability of PBP1510

+2 more

Secondary outcome measures

PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of PBP1510 (hr*µg /ml)

PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of gemcitabine (hr*µg /ml)

PART 1 (PHASE 1): Clearance (CL) of PBP1510 (mL/kg/hr)

+32 more

Other outcome measures

PART 1 (PHASE 1) Exploratory Endpoint: Analysis of PAUF in tumour tissue pre-treatment and after treatment with PBP1510 administered as monotherapy, and in combination with gemcitabine.

PART 1 (PHASE 1) Exploratory Endpoint: Preliminary evidence of clinical outcomes as assessed by objective response rate (ORR) after treatment with PBP1510 administered as monotherapy, and in combination with gemcitabine.

PART 2 (PHASE 2a) Exploratory Endpoint: Analysis of PAUF in tumour tissue pre-treatment and after treatment with PBP1510 administered in combination with gemcitabine.

+1 more

Trial Design

10Treatment groups

Experimental Treatment

Group I: Cohort 5MExperimental Treatment1 Intervention

15 mg/kg of PBP1510 as monotherapy will be administered

Group II: Cohort 5CExperimental Treatment2 Interventions

15 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered

Group III: Cohort 4MExperimental Treatment1 Intervention

10 mg/kg of PBP1510 as monotherapy will be administered

Group IV: Cohort 4CExperimental Treatment2 Interventions

10 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered

Group V: Cohort 3MExperimental Treatment1 Intervention

6 mg/kg of PBP1510 as monotherapy will be administered

Group VI: Cohort 3CExperimental Treatment2 Interventions

6 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered

Group VII: Cohort 2MExperimental Treatment1 Intervention

3 mg/kg of PBP1510 as monotherapy will be administered

Group VIII: Cohort 2CExperimental Treatment2 Interventions

3 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered

Group IX: Cohort 1MExperimental Treatment1 Intervention

1 mg/kg of PBP1510 as monotherapy will be administered

Group X: Cohort 1CExperimental Treatment2 Interventions

1 mg/kg of PBP1510 and 1000 mg/m^2 of gemcitabine as combination therapy will be administered

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Prestige Biopharma LimitedLead Sponsor

5 Previous Clinical Trials

1,701 Total Patients Enrolled

Peggy FeyaertsStudy ChairPrestige Biopharma Limited

1 Previous Clinical Trials

324 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for this medical trial?

"The details provided on clinicaltrials.gov suggest that recruitment is in progress for this trial, which was originally declared open to enrollment on June 5th 2023 and most recently edited November 8th 2023."

Answered by AI

How many volunteers are being accepted into this experiment?

"Affirmative. Clinicaltrials.gov lists this medical trial, which was launched on June 5th 2023, as currently open for recruitment. 80 participants are required to be enrolled at two separate clinical sites."

Answered by AI

What aims is this clinical trial hoping to achieve?

"The primary outcome of this medical trial, which will be monitored from Baseline to Safety Follow Up (90 days after the last dose of PBP1510) is determining Dose Limiting Toxicity (DLT). Secondary objectives include measuring Mean Residence Time (MRT), Terminal Elimination Half-Life (t1/2), and Time To Reach Cmax (Tmax) for both Gemcitabine and PBP1510 when administered together intravenously in patients with pancreatic cancer that have progressed following one line of chemotherapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05141149.