eligibility_summary
Eligibility: HLA-A02:01 and MAGE-A4–positive selected advanced solid tumors, ECOG 0–1, measurable disease, adequate organ function, relapsed/refractory/intolerant to standard therapy, consent, contraception if needed. Excludes: symptomatic or untreated CNS mets, inadequate washout or ongoing toxicities, recent surgery, cardiac disease, active infection (HIV at AIDS risk, HBV/HCV), steroids/immunosuppression, secondary malignancy, autoimmune disease requiring treatment, uncontrolled illness, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CDR404, an IV bispecific, bivalent T‑cell–engaging antibody (biologic). Mechanism: one arm binds CD3 on T cells, the other recognizes MAGE‑A4 peptide presented by HLA‑A02:01 on tumor cells, bridging T cells to cancer cells to form an immune synapse, activate TCR/CD3 signaling, trigger cytotoxic killing and cytokine release, and eliminate MAGE‑A4–positive tumors. Targets: CD3+ T cells (activation via TCR/CD3 pathway) and tumor cells expressing the cancer‑testis antigen MAGE‑A4 in the context of HLA‑A02:01 (peptide–HLA complex). Trial: Phase 1, first‑in‑human IV dose escalation to determine MTD/PEDR, safety, PK, immunogenicity, biomarkers, and preliminary antitumor activity in adults with advanced solid tumors, enrollment requires HLA‑A02:01 and MAGE‑A4 positivity.