Phase 1 Pancreatic Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who agree to follow the trial schedule and procedures, and have signed a consent form.
• People who are 18 years of age or older at the time of signing the consent form, regardless of gender.
• People with advanced, inoperable, or metastatic pancreatic cancer who have already tried at least two rounds of chemotherapy that either did not work or could not be tolerated; or people with advanced non-small cell lung cancer (NSCLC) who have already tried platinum-based chemotherapy and a specific type of immunotherapy (anti-PD-1/PD-L1) that either did not work or could not be tolerated — and, if their tumour tested positive for certain gene changes (EGFR or ALK), treatment with a specific type of targeted therapy (third-generation TKI) must also have been tried and failed or not tolerated.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People with a good general health and activity level, as measured by a standard scale (ECOG score of 0 or 1) (confirm with trial site).
• People whose doctors estimate they are likely to live for at least 12 weeks.
• People whose blood counts and organ function (including bone marrow, liver, kidneys, and blood clotting) meet specific laboratory levels set by the trial (confirm with trial site for exact values).
• People who are willing to use effective contraception from the time of signing the consent form until 6 months after the last dose of the trial drug; women who could become pregnant must have a negative pregnancy test within 7 days before the first dose.

Who may not be able to join:

• People who are known to be allergic to the trial drug (TMT101 Injection) or any of its ingredients.
• People with serious uncontrolled health conditions, including active infections needing systemic treatment, uncontrolled high blood pressure or blood sugar, heart failure, unstable chest pain, heart rhythm problems requiring treatment, significant fluid build-up in the abdomen or chest, blood clots or history of stroke or heart attack, active autoimmune disease, serious psychiatric illness, active stomach ulcers, or active bleeding disorders.
• People who have taken immune-suppressing medications within 3 weeks before the first dose, or who have been on systemic steroid therapy at doses above a certain level for at least 7 days (with some exceptions for low-dose nasal or inhaled steroids).
• People who have had major surgery, radiotherapy (other than palliative treatment for bone pain), or unhealed surgical wounds within 4 weeks before the first dose; or who have received chemotherapy, immunotherapy, targeted therapy, or other anti-cancer treatments within 4 weeks before the first dose (or within 5 half-lives of the drug, whichever is shorter).
• People who have had or currently have another cancer, with two exceptions: cervical or breast cancer in situ that was fully treated with no signs of return for at least 3 years, or a previous cancer that was completely removed and has been in full remission for 5 or more years.
• People with a history of, current, or suspected scarring lung disease (interstitial lung disease), or who have previously needed steroid treatment for lung inflammation (pneumonitis).
• People who test positive for syphilis, HIV, active hepatitis B, or active hepatitis C.
• People who have received live vaccines (such as measles, mumps, chickenpox, yellow fever, rabies, BCG, or typhoid) within 4 weeks before the first dose, or who plan to receive live vaccines during the trial or within 4 weeks after the last dose.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
• People who are currently taking part in another clinical trial that involves an active treatment, if the investigator considers this unsuitable.
• People who have previously experienced a severe (grade 3 or higher) immune-related side effect from immunotherapy, or a serious adverse event from immunotherapy that led to permanently stopping that treatment.
• People who are pregnant or breastfeeding.
• People with active cancer that has spread to the brain or spinal cord and is causing symptoms, or cancer affecting the membranes around the brain (meningeal metastases) — though people with brain metastases that are not causing symptoms may still be considered.
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments that have not yet resolved, with some exceptions such as hair loss, long-term effects from radiotherapy, or other lasting effects that the investigator judges are not affecting the person's ability to take part.
• People who have had major surgery within 4 weeks before the first dose.
• People for whom the investigator considers removal of the spleen to be unsuitable (confirm with trial site).
• People who, in the investigator's opinion, have any other condition that may affect their ability to follow the trial requirements safely.

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