Study on Emiltatug Ledadotin (Emi-Le) for Patients with Solid Tumors

Inclusion Criteria

• Have a solid tumor that has come back or is advanced.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have at least one measurable tumor that can be tracked using standard criteria.
• Be able to provide a tumor sample for testing, either from a previous biopsy or a new one, if safe to do so.
• Have a brain MRI during the screening period if you have triple-negative breast cancer (TNBC) or a history of brain metastases, or if you have symptoms suggesting brain metastases.

Exclusion Criteria

• Have previously been treated with a specific type of drug called an Antibody Drug Conjugate (ADC) that contains an auristatin payload.
• Have had major surgery within 28 days before starting the study treatment.
• Have received systemic anticancer therapy recently, within 28 days or 5 half-lives of the previous treatment, whichever is shorter.
• Have had palliative radiation therapy to the chest within 3 months or to other areas within 14 days before starting the study treatment.
• Have another active cancer that required treatment within the last 2 years, except for certain skin cancers or carcinoma in situ of the breast or cervix.
• Have untreated or worsening brain metastases or a history of certain types of cancer spread to the brain or spinal cord.
• Have previously received treatment targeting B7-H4.
• Have significant liver disease or conditions like cirrhosis or liver fibrosis.
• Have severe, uncontrolled systemic diseases or illnesses that could increase the risk of serious side effects or interfere with the study.
• Have significant heart disease or active inflammation of the cornea (keratitis).