eligibility_summary
Adults ≥18, incurable disease after SoC, RECIST-measurable lesion, ECOG 0–1, life expectancy >12 wks, adequate organs, prior AEs ≤G1, consent/tissue, HRCT/PFT, contraception. Exclude: pregnancy, allergy to exatecan/deruxtecan/camptothecan, topo‑I–refractory, recent trials, RT<2w or surgery, CNS/cord disease, ILD/pneumonitis, SpO2<93%, FVC<60%/DLCO<70%, QTcF>470, nephrotic/corneal disease, serious organ/cardiac issues, concurrent anticancer therapy, live vaccines, active infection (controlled HBV/HCV/HIV ok), PML.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06303505 tests TUB-040, an antibody–drug conjugate (ADC) given IV q3w, in platinum‑resistant high‑grade ovarian cancer and relapsed/refractory adenocarcinoma NSCLC. Drug/intervention: TUB-040 (ADC). Mechanism: a monoclonal antibody targets NaPi2b (SLC34A2, a sodium‑dependent phosphate transporter) on tumor cells, after binding and internalization, a topoisomerase I inhibitor (exatecan/camptothecan class payload) is released, inhibiting topo I, causing replication‑associated DNA breaks and cell death. Targeted cells/pathways: tumor cells overexpressing NaPi2b in ovarian and lung adenocarcinomas, pathways include NaPi2b‑mediated receptor internalization/endocytosis, topoisomerase I–dependent DNA replication/transcription, and DNA damage response leading to apoptosis. Phase I/IIa dose escalation and dose optimization to define MTD/optimal dose and assess safety, PK, and preliminary efficacy.