NCT06714617

Who might be able to join this trial:

• You are 18 years old or older
• You weigh more than 40 kg (about 88 lbs); if the dose being tested is below a certain level, you must weigh at least 70 kg (about 154 lbs)
• You have a life expectancy of at least 3 months
• You have been diagnosed with an advanced or spreading solid tumor that tests positive for a protein called HER2 (or has a HER2 gene mutation), cannot be cured by surgery or radiation, and have already tried at least one standard treatment — or no standard treatment exists for your cancer type; eligible cancer types include breast, stomach/gastroesophageal junction, non-small cell lung, endometrial, ovarian (including fallopian tube and primary peritoneal), bladder/urinary tract cancers, or other HER2-positive solid tumors (confirm with trial site)
• You are willing to provide an existing tumor tissue sample, or in some cases a new biopsy, for laboratory testing
• You have at least one tumor that can be measured on a scan
• You are generally able to carry out daily activities with little or no restriction (confirmed by a standard health performance scale)
• Any side effects from your previous cancer treatments have mostly resolved
• Your heart is functioning well, with the heart's pumping strength (left ventricular ejection fraction) at 50% or above
• Your blood counts, liver, and kidney function are within acceptable ranges as shown by recent lab tests
• Your blood clotting levels are within an acceptable range
• Your urine protein levels are within an acceptable range
• If you are sexually active and able to have children, you and your partner agree to use highly effective birth control during the study and for 7 months after the last dose
• If you are a woman who could become pregnant, you have a negative pregnancy test at the start of the study and are not breastfeeding

Who may not be able to join:

• You received chemotherapy, immunotherapy, targeted therapy, or other cancer treatments within the past 4 weeks (or 5 half-lives, whichever is shorter), had major surgery within the past 4 weeks, or received certain specific chemotherapy drugs (mitomycin or nitrosoureas) within the past 6 weeks
• You are currently taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors/inducers or P-gp transporter inhibitors/inducers) (confirm with trial site)
• You have a history of serious heart problems, such as significant heart failure, a heart attack, or unstable chest pain within the past 6 months
• You have certain heart rhythm abnormalities or a personal or family history of a condition called long QT syndrome, or you take medications known to affect heart rhythm (confirm with trial site)
• You have an active autoimmune or inflammatory disease (such as lupus, rheumatoid arthritis, or inflammatory bowel disease), with some exceptions for well-controlled conditions like hypothyroidism or type 1 diabetes
• You have had another type of cancer in the past, unless it was a certain type of skin cancer that was fully treated, or another cancer that was treated with curative intent and you have been cancer-free for at least 3 years
• Your high blood pressure is not well controlled even with two types of blood pressure medications
• You have serious or poorly controlled lung disease, such as severe COPD, asthma, or pulmonary hypertension
• You have a history of a lung inflammation condition called interstitial lung disease (ILD) or pneumonitis that needed steroid treatment, or you currently have this condition
• You had a stroke or mini-stroke (TIA) within the past 6 months
• You had a blood clot (such as deep vein thrombosis or a pulmonary embolism) within the past 6 months, unless you have been stable on blood-thinning treatment for at least 3 weeks
• You have active or untreated cancer that has spread to the brain or the lining of the brain; however, previously treated brain metastases may be acceptable if you have been stable for at least 4 weeks and meet certain other conditions (confirm with trial site)
• You have pre-existing moderate or severe nerve damage (peripheral neuropathy at Grade 2 or higher)
• You have had a severe allergic reaction to