What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and its combinations (e.g., with nab-paclitaxel), are associated with several side effects. These include neutropenia, fatigue, neuropathy, nausea, and diarrhea. Specifically, gemcitabine plus nab-paclitaxel can cause grade 3 or 4 toxicities like neutropenia (38-49%), fatigue (17-27%), neuropathy (17-20%), and diarrhea (6-12%). These side effects are significant considerations for patients undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapy regimens such as FOLFIRINOX (a combination of leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine-based therapies. Notably, gemcitabine combined with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has shown significant efficacy in improving survival rates. Additionally, targeted therapies like PARP inhibitors are used for patients with specific genetic mutations such as BRCA or PALB2. These treatments aim to improve survival and manage symptoms in patients with advanced pancreatic cancer.

What other types of research exist?

Promising novel alternatives to PBP1510 for pancreatic cancer patients in 2024 include: 1) Dendritic cell vaccine loaded with WT1 peptides (TLP0-001) in combination with S-1, and 2) A therapeutic peptide based on thermo-responsive elastin-like polypeptide in combination with gemcitabine.

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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.

Must not have

A history of allergic reactions attributed to gemcitabine or compounds of similar chemical composition to gemcitabine and/or previous treatment discontinuation due to gemcitabine toxicity.

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

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

Summary

This trial is testing a new drug called PBP1510, alone or with gemcitabine, in patients with advanced pancreatic cancer that hasn't responded to previous treatments. The goal is to see if PBP1510 can help stop or slow down the growth of their tumors. Gemcitabine has been a standard treatment for advanced pancreatic cancer, often used alone or in combination with other drugs to improve efficacy.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to gemcitabine or have had severe side effects from it.

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I am currently undergoing radiation therapy or finished it within the last 4 weeks.

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I do not have any active infections needing strong medication.

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I have been diagnosed with HIV.

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I have or had hepatitis B, hepatitis C, or syphilis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine and nab-paclitaxel, which work by inhibiting DNA synthesis and disrupting microtubule function, respectively, leading to cancer cell death. Targeted therapies, like PARP inhibitors, exploit specific genetic vulnerabilities in cancer cells, such as BRCA mutations, to induce synthetic lethality. Novel agents like PBP1510 aim to target unique proteins or pathways specific to pancreatic cancer cells, potentially offering more effective and less toxic treatment options. Understanding these mechanisms is crucial for patients as it informs treatment choices and helps predict responses and potential side effects.

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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

~41 spots leftby Feb 2026

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