Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma

Inclusion Criteria

• •1. Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good clinical practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses
• •2. Male or female patients ≥18 years old at the time of signature of the ICF
• •3. Histologically proven diagnosis of one of the following:
• •* Undifferentiated pleomorphic sarcoma (UPS) with TP53 wild-type status
• •* Myxofibrosarcoma (MFS) with TP53 wild-type status
• •4. Written pathology report indicating the diagnosis of UPS or MFS must be available
• •5. Written report from the trial central laboratory indicating TP53 wild-type status
• •6. One prior systemic regimen for advanced disease with documented progressive disease as per serial radiologic imaging. If prior systemic cytotoxic treatment for soft tissue sarcoma was given in a neoadjuvant, adjuvant or perioperative setting that treatment would count as one line of therapy in case of radiological progression during that treatment or within 3 months after completing that systemic therapy. If progression or relapse occurred after \>3 months after completing that systemic therapy, the pre-, post or perioperative treatment would not count as a line of treatment for advanced disease
• •7. Patient must be willing to donate mandatory blood and tissue samples for the pharmacokinetics, pharmacodynamics, and biomarker analyses