Phase 2 Rare Disease 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 who are willing and able to sign a written consent form agreeing to take part
• People aged 18 or older
• People who have been diagnosed with an advanced tumour confirmed by tissue or cell testing, along with imaging, and whose tumour tests positive for a protein called HER2 (HER2 score of 1+ or higher on a standard lab test)
• (Cohort 1 only) People with a confirmed diagnosis of extramammary Paget's disease (a rare skin cancer affecting areas outside the breast) that has spread or cannot be surgically removed
• (Cohort 2 only) People with a confirmed diagnosis of a locally advanced or metastatic rare solid tumour (such as sarcoma or urachal cancer) that has stopped responding to standard treatment, or for which no standard treatment exists
• (Cohort 3 only) People with a confirmed diagnosis of locally advanced or metastatic bladder/urinary tract cancer (urothelial carcinoma) whose disease has continued to grow after first-line treatment combining a specific type of immunotherapy (PD-1/PD-L1 inhibitor) with either enfortumab vedotin or disitamab vedotin
• People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out at least some daily activities, though not necessarily all)
• People who have at least one tumour that can be measured on a scan (meeting specific size requirements set out in standard imaging guidelines)
• People whose blood cell counts, liver function, kidney function, and blood clotting results fall within ranges acceptable to the trial (confirm specific values with the trial site)
• People with an estimated life expectancy of at least 3 months
• People who are willing and able to use medically approved contraception throughout the treatment period and for at least 120 days after the study ends, and who agree not to donate or store sperm for fertilisation during this time
• People who are able to attend all required visits and follow the study plan

Who may not be able to join:

• People with poorly controlled high blood pressure or poorly controlled diabetes
• People with significant heart problems, including moderate-to-severe heart disease, irregular heartbeat (with a specific electrical reading outside the acceptable range), or moderate-to-severe heart failure
• People with an active or uncontrolled serious infection requiring treatment with antibiotics, antifungals, or antivirals, including active tuberculosis
• People with a history of active tuberculosis
• People with uncontrolled build-up of fluid in the abdomen, around the heart, or in the lungs that requires repeated draining
• People with active hepatitis B or C at levels above those accepted by the trial (note: people who carry the hepatitis B virus at low levels may still be considered if they receive antiviral treatment during the trial — confirm with trial site)
• People with HIV or any other condition that significantly weakens the immune system
• People who have previously received a transplanted organ or bone marrow/stem cells from another person
• People with known cancer spread to the brain, the lining of the brain or spinal cord, or the spine
• People who, within the 6 months before starting the trial, have had serious gastrointestinal problems such as bleeding, perforations, fistulas, blockages, abscesses, severe ulcers, or major bowel surgery, or who have Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea
• People with wounds or ulcers that have not healed properly
• People still experiencing side effects from previous cancer treatment that have not settled to a mild level (with the exception of hair loss)
• People who have had major surgery, an open biopsy, or a serious injury within 28 days before starting the study, or who have long-term unhealed wounds or fractures
• People with a history of severe allergic reactions to medicines in the same class as the study drug, or known allergies to ingredients in the study drugs
• People who have taken part in another clinical trial within 4 weeks before starting this study
• People who have received a live vaccine within 30 days before starting the study, or who plan to receive one during the study
• People with a history of severe allergies
• People with a tendency to bleed, a blood clotting disorder, or who are currently receiving clot-dissolving therapy
• People with a history of drug misuse or psychiatric disorders
• People with a known neurological or psychiatric condition such as dementia, epilepsy, or a tendency to have seizures
• People whose overall circumstances — including health, personal, family, social, or geographical factors — may make it difficult to safely complete the study (as assessed by the treating doctor)
• People considered unsuitable for any other reason, at the discretion of the treating doctor

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