Early 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:

• People aged 18 or older with advanced, spreading, or inoperable solid tumours that have been confirmed by laboratory testing of tumour tissue or cells, and whose cancer has not responded to standard treatments, has no standard treatment options available, or who have chosen not to pursue standard treatment
• People with one of these specific cancer types and treatment histories:
  • Advanced or spreading triple-negative breast cancer (TNBC) that has stopped responding to, or caused intolerable side effects from, at least 2 previous systemic (whole-body) treatment regimens
  • Advanced or spreading HER2-positive breast cancer that has stopped responding to, or caused intolerable side effects from, at least 2 previous HER2-targeted treatment regimens
  • Advanced or spreading breast cancer that is both hormone receptor-negative and HER2-negative, and has stopped responding to, or caused intolerable side effects from, at least 2 previous systemic treatment regimens
  • Advanced or spreading high-grade soft tissue sarcoma (excluding a type called chordoma) that has stopped responding to, or caused intolerable side effects from, at least 1 previous systemic treatment regimen
  • Advanced or spreading pancreatic cancer that has stopped responding to, or caused intolerable side effects from, at least 1 previous systemic treatment regimen
• People who are able to understand the study information, sign a consent form, and are willing and able to follow the study procedures and attend follow-up visits
• People who are in good enough general health to be largely active and able to carry out daily activities (this is measured using a standard scale called ECOG, with a score of 0 or 1)
• People whose tumour has tested positive for a protein called FAP, confirmed by a type of body scan called FAPI PET/CT
• People who are willing to provide stored or freshly collected tumour tissue for testing, if it is available
• People who have at least one tumour that can be measured using standard imaging criteria (known as RECIST 1.1)
• People whose side effects from previous cancer treatments have resolved to mild or no symptoms
• People whose blood counts, liver function, kidney function, and heart electrical activity meet the specific levels required by the trial (confirm with trial site for exact values)
• People who are capable of having children and who agree to use effective contraception throughout treatment and for 4 months after the last dose (for males) or 7 months after the last dose (for females)

Who may not be able to join:

• People who have cancer that has spread to the brain, tumours on the lining of the brain, or other central nervous system involvement at the time of screening
• People with a severe allergy to contrast dyes used in scans, or who experience severe anxiety in enclosed spaces (claustrophobia)
• People whose expected survival is less than 6 months
• People who received a blood transfusion within 2 weeks before the first dose of the study drug (if given specifically to meet the eligibility blood count requirements)
• People who received any systemic anti-cancer treatment — such as targeted therapy, immunotherapy, chemotherapy, or certain traditional medicines with anti-tumour effects — within 4 weeks before the first dose
• People who have taken part in another clinical trial involving an experimental drug or device within 4 weeks before the first dose
• People who had major surgery within 4 weeks before the first dose, or who have major surgery planned during the study
• People who have had a serious active infection requiring intravenous (drip) antibiotics or antiviral medicines within 4 weeks before the first dose
• People who have previously received radioactive (radionuclide) therapy to the whole body — except radioactive iodine treatment for thyroid cancer — or external beam radiation therapy within 4 weeks before the first dose
• People who have had another type of cancer diagnosed within the past 5 years
• People with serious heart or blood vessel disease, serious brain or stroke-related conditions, or poorly controlled diabetes
• People who have a build-up of fluid around the lungs or in the abdomen that requires treatment or is considered uncontrolled at the time of screening
• People who are pregnant or breastfeeding
• People who the trial doctor believes are unlikely to reliably follow the treatment plan and attend required follow-up visits

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