eligibility_summary
Adults ≥18, ECOG 0–1, life ≥3 mo, CEACAM5+ with biopsiable, measurable lesion. Indications: metastatic NS‑NSCLC (no EGFR/ALK/ROS, ≤1 platinum, ≤1 IO), ER+ breast (hormone‑refractory, ≤1 chemo), or gastric post‑SOC. Key exclusions: active brain mets, recent TE, unresolved tox, ocular disease or ≥G2 neuropathy, prior CEACAM5/DM4, strong CYP3A or narrow‑TI CYP meds, other therapy/trials, organ dysfunction/low albumin, pregnancy/contraception, cannot pause anticoagulants.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05703555 (withdrawn) evaluated tusamitamab ravtansine (SAR408701), an antibody–drug conjugate (ADC) given 100 mg/m2 IV q2w. Drug/type and mechanism: an anti-CEACAM5 monoclonal antibody linked to the maytansinoid DM4 (ravtansine), a microtubule inhibitor. It binds CEACAM5 on tumor cells, is internalized, then releases DM4 to inhibit tubulin polymerization, causing mitotic arrest and apoptosis. Targets: CEACAM5 (CEA, cell adhesion molecule) on CEACAM5-positive tumors—non-squamous NSCLC, ER+ breast cancer, and gastric cancer. Pathways/cells affected: CEACAM5-expressing tumor cells and microtubule dynamics/cell cycle. Study goal: define intratumoral PK/PD relationships of the ADC and CEACAM5 expression.