First in Human Study of Anti-PAUF Monoclonal Antibody PBP1510 for Pancreatic Cancer

Sponsor: Prestige Biopharma Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05141149

Provider View

This clinical trial is testing a new treatment called PBP1510 for patients with advanced pancreatic cancer. The study will explore how safe and effective this treatment is, both on its own and in combination with another drug called gemcitabine.

Patient Parameters

Program Overview

This study is the first to test a new treatment, PBP1510, in humans. It is designed for patients with advanced or metastatic pancreatic cancer. The trial will be conducted in two parts. In the first part, researchers will test different doses of PBP1510, both alone and with gemcitabine, to find the best dose. In the second part, they will use the best dose found in the first part, combined with gemcitabine, to see how well it works in more patients.

Description

This clinical trial is exploring a new treatment called PBP1510 for patients with advanced pancreatic cancer. The study is divided into two phases. In the first phase, researchers will test different doses of PBP1510, both as a standalone treatment and in combination with a chemotherapy drug called gemcitabine. This phase aims to find the safest and most effective dose. In the second phase, the best dose from the first phase will be used in combination with gemcitabine to treat more patients and further assess its effectiveness.

Participants in the study must have advanced pancreatic cancer that has progressed after at least one previous chemotherapy treatment. The study will take place at multiple centers and will involve regular health checks and tests to monitor the safety and effectiveness of the treatment. The goal is to determine if PBP1510 can help control pancreatic cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must understand and sign a consent form before starting the study.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Must have a confirmed diagnosis of advanced or metastatic pancreatic cancer.
  • Must have a life expectancy of at least 3 months.
  • Must not have any other cancer that would interfere with the study treatment.
  • Must have completed any prior radiation therapy at least 4 weeks before starting the study.
  • Must have at least one measurable tumor.
  • Must have adequate organ function based on specific blood tests.
  • Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
  • Men with partners who can become pregnant must agree to use effective birth control during the study and for 6 months after.
  • Must be willing to follow all study procedures and attend scheduled visits.
  • For Phase 1: Must have advanced pancreatic cancer that has progressed after at least one prior chemotherapy treatment.
  • For Phase 2: Must have advanced pancreatic cancer that has progressed after one prior chemotherapy treatment.

Exclusion Criteria

  • Cannot have known brain metastases unless previously treated and stable for at least 3 months.
  • Cannot have had major surgery within 4 weeks before starting the study, except for minor procedures.
  • Cannot have active, uncontrolled infections requiring treatment.
  • Cannot have a history of HIV, hepatitis B, hepatitis C, or syphilis.
  • Cannot have significant heart problems or uncontrolled high blood pressure.
  • Cannot have serious psychiatric disorders.
  • Cannot have had another cancer within the last 5 years, except for certain skin cancers.
  • Cannot be enrolled in another clinical trial.
  • Cannot be receiving radiation therapy or have had it within 4 weeks before the study.
  • Cannot have received an investigational drug or chemotherapy within 4 weeks before the study.
  • Cannot have allergies to PBP1510 or its components.
  • Cannot be pregnant or breastfeeding.
  • Cannot be unwilling or unable to follow study procedures.
  • Cannot have a history of allergic reactions to gemcitabine or similar drugs.

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