eligibility_summary
Adults (≥18) with ECOG 0-1, progressing, measurable advanced cancer and tissue available (biopsy or recent archival). Cohorts: EC, HNSCC (no major vessel invasion, no recent ≥G3 bleeding, p16 documented), PDAC (no prior topo-I), CRC MSS (no prior topo-I), HCC (BCLC B/C, CP-A, ALBI 1, treat varices), Ad-eso/GEJ/Gastric, UC (prior ICI+chemo incl EV if available), CC, OVC (not primary platinum refractory), BTC, HER2-low post T-DXd, HER2 IHC0, cutaneous melanoma. Exclude prior B7-H3 therapy, exatecan-ADC discontinuation, active CNS mets, inadequate washout.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06330064 (IDeate-PanTumor02), Phase 1b/2, open-label, pan-tumor. Intervention: Ifinatamab deruxtecan (I-DXd, DS-7300a), an antibody–drug conjugate (ADC). Mechanism: a humanized anti–B7-H3 (CD276) IgG1 monoclonal antibody linked via a cleavable linker to a deruxtecan (DXd) topoisomerase I inhibitor payload. After binding B7-H3 and internalization, the linker is cleaved to release DXd, inducing DNA damage and apoptosis, the membrane-permeable payload can cause a bystander effect. The mAb may also engage Fc-mediated ADCC/ADCP. Target cells/pathways: B7-H3–expressing tumor cells and tumor-associated vasculature/stroma, downstream cytotoxic effect via inhibition of DNA topoisomerase I. Indications: multiple recurrent/metastatic solid tumors (EC, HNSCC, PDAC, CRC-MSS, HCC, Ad-eso/GEJ/gastric, UC, OVC, CC, BTC, HER2-low and HER2 IHC0 breast cancer, cutaneous melanoma). All cohorts receive I-DXd IV (typically 12 mg/kg, HCC includes a safety run-in to determine dose).