Phase 1 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:

For the dose escalation and combination treatment parts of the trial:

• People who are 18 years of age or older
• People who have been diagnosed with a specific type of ovarian cancer (high-grade serous or endometrioid epithelial ovarian cancer), triple-negative breast cancer (TNBC), or a non-squamous type of non-small cell lung cancer (NSCLC) — and for the combination treatment part, also people with ductal pancreatic cancer (confirm with trial site)
• People whose tumor tissue shows a certain level of a protein called mesothelin (MSLN) when tested in a lab — this can be checked using stored tissue samples
• People whose cancer has spread, come back, or is at an advanced stage, and who have already tried at least one prior cancer treatment that did not work, was not tolerated, or where no other suitable treatments are available
• People whose cancer can be measured on scans, following standard medical guidelines
• People who are well enough to carry out basic daily activities without being confined to bed (based on a standard medical scale called ECOG, scoring 0 or 1)
• People who have a negative pregnancy test at the time of joining
• People who are expected to live for at least 2 more months
• People with tumors that can be safely biopsied, if joining the expansion or combination treatment parts of the trial

For the randomised study part of the trial (ovarian cancer only):

• Women who are 18 years of age or older
• Women who have been confirmed to have high-grade serous epithelial ovarian cancer
• Women whose cancer has stopped responding to platinum-based chemotherapy within a specific timeframe (the trial site will assess whether this applies based on individual treatment history)
• Women whose cancer has grown or spread since their most recent treatment, confirmed by scans
• Women who are willing to provide stored tumor tissue or have a new biopsy taken, to confirm mesothelin protein levels
• Women whose tumor tissue shows a certain level of mesothelin (MSLN) when tested in a lab
• Women who have at least one area of cancer that can be measured on scans
• Women who have received between 1 and 3 prior cancer treatments, and for whom a single-drug treatment approach is considered appropriate as the next step (confirm with trial site for how prior treatments are counted)
• Women with an ECOG performance status of 0 or 1 (well enough to carry out basic daily activities)
• Women whose side effects from previous treatments have settled to a mild level or returned to their normal baseline
• Women who have had any major surgery at least 4 weeks before the first dose and have recovered from it
• Women with adequate blood, liver, and kidney function based on lab tests
• Women who have a negative pregnancy test at the time of joining

Who may not be able to join:

For the dose escalation and combination treatment parts of the trial:

• People who have had a known allergic reaction to NI-1801 (the study drug) or any of its ingredients
• People who have had radiation therapy to the areas being measured for the trial within the 4 weeks before starting the study drug
• People who have received other cancer treatments (such as chemotherapy or hormonal therapy) too recently before starting the study drug (specific timeframes apply — confirm with trial site)
• People who are currently taking part in another clinical trial
• People with severe heart failure (classified as NYHA class III or IV)
• People with significant liver problems, unless caused directly by liver metastases (confirm with trial site)
• People with a known HIV infection, or a history of hepatitis B or C, or an active COVID-19 infection
• People with an active, uncontrolled infection (bacterial, viral, fungal, or other) that has not improved with treatment
• People who have another active cancer requiring ongoing treatment
• People with known cancer spread to the brain or central nervous system
• People with very low platelet counts, low red blood cell levels, or low white blood cell counts (specific thresholds apply — confirm with trial site)
• People who are pregnant or breastfeeding
• People with a history of psychiatric illness or substance use that could interfere with taking part in the trial
• People with other serious medical conditions that could increase the risk of taking part, including a recent heart attack (within the past 6 months), unstable chest pain (angina), uncontrolled diabetes, or a severely weakened immune system
• People who have previously been treated with a drug that targets CD47, SIRPα, or mesothelin (MSLN)
• People whose side effects from previous cancer treatments have not settled to a mild level
• People who are in legally restricted situations that prevent them from freely giving informed consent (such as being under legal guardianship or detained by a court order)

Additionally, for the combination treatment part (with pembrolizumab) only:

• People with a history of, or currently active, non-infectious lung inflammation (pneumonitis or interstitial lung disease)
• People with a known allergy to pembrolizumab or its ingredients
• People with an active autoimmune disease (some exceptions may apply — confirm with trial site)
• People who have had an organ or tissue transplant from a donor
• People who have had a severe (Grade 3 or higher) reaction to a previous immune checkpoint or T-cell therapy, unless that reaction is unlikely to happen again
• People with a history of heart muscle inflammation (myocarditis), regardless of the cause

For the randomised study part of the trial (ovarian cancer only):

• Women whose ovarian cancer is a specific type not covered by this trial (such as clear cell, mucinous, sarcomatous, mixed, low-grade, or borderline ovarian tumours)
• Women whose cancer never responded to their first platinum-based chemotherapy, or progressed within 3 months of finishing it
• Women who have had extensive radiation therapy covering a large portion of their bone marrow
• Women with serious active infections, including active hepatitis B or C, HIV, cytomegalovirus, or other infections requiring intravenous antibiotics within 2 weeks before starting the study drug
• Women with a history of multiple sclerosis or other nerve-related conditions (confirm with trial site)
• Women with significant heart problems, including a recent heart attack (within 6 months), unstable chest pain, uncontrolled heart failure, uncontrolled high blood pressure, uncontrolled irregular heartbeat, or a recent stroke (within 6 months)
• Women with advanced liver scarring (cirrhosis, Child-Pugh Class B or C)
• Women with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis)
• Women with a known history of allergic reactions to monoclonal antibody treatments
• Women who are pregnant or breastfeeding
• Women who have previously been treated with a drug targeting CD47, SIRPα, or mesothelin (MSLN)
• Women with cancer that has spread to the brain or central nervous system
• Women who have had another type of cancer diagnosed within the past 3 years
• Women with a known allergy to the study drugs or their ingredients

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