eligibility_summary
Adults ≥18 with advanced/metastatic SS, MRCLS, NSCLC (Ad/Sq) or UC, relapsed/refractory/intolerant to SOC, HLA‑A02:01/02/03/04/05/06/09/10/11+, measurable disease, tumor tissue, ECOG 0–1, adequate labs, contraception. Exclude: prior anti–NY‑ESO‑1, inadequate washout, symptomatic CNS mets, significant CV disease, chronic steroids, active other cancers, unresolved ≥G2 tox (some stable G2 ok), biologic hypersensitivity, active autoimmune dz, HIV/HBV/HCV unless controlled (Part 2).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06644755 (Phase 1, first-in-human). Intervention: DS-2243a. Type: Investigational immunotherapy (drug, specific modality not specified in registry). Mechanism of action: Designed for patients whose tumors are HLA-A2–positive and/or NY‑ESO‑1–positive, indicating DS-2243a targets the cancer‑testis antigen NY‑ESO‑1 presented by HLA‑A2 to drive an anti‑tumor immune response. Target cells/pathways: • Tumor cells expressing NY‑ESO‑1 (e.g., synovial sarcoma, myxoid/round cell liposarcoma, NSCLC [squamous and adenocarcinoma], urothelial carcinoma) with HLA‑A02 subtypes. • Immune pathway: antigen-specific adaptive immunity against the NY‑ESO‑1/HLA‑A2 peptide–MHC complex, aiming to enhance T‑cell–mediated cytotoxicity against tumor cells. Design: Dose escalation to define RDE, followed by expansion cohorts in the above tumor types.