Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older (or the legal age of majority in the country where the trial is being run) at the time of giving consent.
• People who are willing and able to understand, sign, and date a written consent form before any trial procedures begin.
• People with a general health and activity level rated at 0 or 1 on the ECOG scale, meaning they are either fully active or have some limits on heavy physical activity but can still do light work (confirm with trial site).
• People who have a confirmed diagnosis of pancreatic cancer that is advanced and/or has spread to other parts of the body, proven through laboratory testing of tissue or cell samples.
• People who are expected to live for at least 3 months.
• People who do not have another active cancer that would interfere with the trial treatment.
• People who have had prior radiation therapy affecting less than 25% of their bone marrow, have fully recovered from its side effects, and completed that radiation at least 4 weeks before starting the trial treatment.
• People who have at least one area of cancer in the body that can be measured using standard imaging criteria (RECIST v1.1).
• People whose blood counts, liver function, kidney function, and heart function all meet the minimum levels required by the trial (confirm specific values with the trial site).
• Women who are not able to become pregnant, meaning they have had a hysterectomy and/or both ovaries removed, have medically confirmed ovarian failure, or have been through menopause (no periods for at least 12 consecutive months with a hormone level test confirming this).
• Women who could become pregnant must have a negative pregnancy blood test within 28 days before starting treatment, a negative urine pregnancy test just before the first dose, and must agree to use effective contraception from the start of the trial until at least 6 months after the last dose.
• Women who could become pregnant, and men whose partners could become pregnant, must agree to use two effective forms of contraception from the start of the trial until at least 6 months after the last dose.
• People who are willing and able to follow all scheduled visits, treatment plans, restrictions, tests, and other trial procedures.
• For Phase 1 only: People with advanced or metastatic pancreatic cancer whose cancer has continued to grow after at least one prior standard chemotherapy treatment.
• For Phase 2a only: People with advanced or metastatic pancreatic cancer whose cancer has continued to grow after exactly one prior standard chemotherapy treatment.

Who may not be able to join:

• People with known cancer that has spread to the brain, unless the brain metastasis was previously treated, has been well controlled for at least 3 months, and the person is no longer taking steroids for it.
• People who have had a major surgery within 4 weeks before the start of trial treatment (some minor procedures may be acceptable — confirm with trial site).
• People who have an active, uncontrolled infection caused by bacteria, viruses, or fungi that requires ongoing treatment with certain drugs.
• People with a known history of HIV.
• People with a known history of, or currently active, hepatitis B, hepatitis C, or syphilis.
• People with significant heart problems or uncontrolled high blood pressure that the treating doctor considers a safety concern.
• People with serious mental health conditions that the treating doctor considers a safety concern.
• People who have had another type of cancer within the past 5 years, except for certain fully treated skin cancers (basal or squamous cell skin cancer).
• People who are currently enrolled in another therapeutic clinical trial.
• People currently receiving radiation therapy, or who have received radiation within 4 weeks before joining the trial.
• People who have received an experimental cancer drug within 28 days (or 5 half-lives, whichever is longer), or standard chemotherapy within 4 weeks, before the first dose of the trial treatment.
• People with a known allergy or serious reaction to any ingredient in the trial drug (PBP1510), to products made from Chinese hamster ovary cells, or to similar antibody-based treatments.
• People who are pregnant or breastfeeding.
• People who are unwilling or unable to follow the trial procedures.
• People whom the trial investigators determine are not suitable to participate for any other reason.
• People with a history of allergic reactions to the chemotherapy drug gemcitabine, or who previously had to stop gemcitabine treatment because of serious side effects. (Note: having used gemcitabine in the past without these issues does not automatically exclude someone from the trial.)

Important: Always verify eligibility with the trial site directly before applying.