eligibility_summary
Eligibility: Unresectable advanced/metastatic STS after ≥1 anthracycline line, or IDH‑wildtype glioblastoma relapsing ≥3 months after radiotherapy with only one prior line (RT ± temozolomide). Residual disease post-surgery allowed if surgery ≥4 weeks prior. ECOG 0–1 and adequate organ function required. Exclude: other malignancy within 3 years (limited exceptions), STS with brain/leptomeningeal mets or cord compression. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: M3554, an anti-GD2 antibody-drug conjugate (ADC). Type: targeted immunotherapy/chemotherapy conjugate. Mechanism of action: The monoclonal antibody binds the GD2 cell-surface antigen on tumor cells, is internalized, and releases an exatecan-based topoisomerase I (TOP1) inhibitor payload, causing TOP1 inhibition, DNA damage (single-strand breaks), replication stress, and tumor cell death. Targets (cells/pathways): GD2-positive tumor cells in soft tissue sarcomas and IDH-wildtype glioblastoma, GD2 ganglioside antigen on the tumor cell membrane, the DNA replication/DNA damage response pathway via TOP1. Study goal: establish MTD/RP2D, assess safety, and preliminary antitumor activity.