IDeate-PanTumor02: A phase 1b/2 study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients (pts) with recurrent or metastatic solid tumors.

作者：Takahiro Kogawa, Seiichiro Mitani, David Berz, Diego Dos Santos Reis, Cindy Li, Tatiane Cristine Ishida, Keyi Wang, Kristi E. Schmidt, Shigehiro Koganemaru · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.tps3157 · 被引用次数：4 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Research Studies、Cancer therapeutics and mechanisms

TPS3157 Background: B7-H3 is highly expressed in many solid tumors but has limited expression in normal tissues; high B7-H3 expression is associated with shorter overall survival (OS) in several tumor types. I-DXd is a B7-H3–directed antibody–drug conjugate (anti−B7-H3 mAb covalently linked to a topoisomerase I inhibitor cytotoxic payload [DXd] via an enzymatically cleavable peptide-based linker). It showed promising efficacy in pts with advanced solid tumors in the Phase 1/2 IDeate-PanTumor01 study, with objective responses in 6 of the 7 tumor types with ≥5 pts (small cell lung cancer [SCLC], esophageal squamous cell carcinoma, metastatic castration-resistant prostate cancer, squamous non-small cell lung cancer, head and neck squamous cell carcinoma [HNSCC], and endometrial cancer). I-DXd also showed encouraging antitumor activity in 88 pretreated pts with extensive-stage SCLC in the Phase 2 IDeate-Lung01 study, with greater efficacy at the 12-mg/kg than the 8-mg/kg dose (objective response rates [ORRs] of 54.8% [95% CI, 38.7–70.2] and 26.1% [95% CI, 14.3–41.1], respectively). I-DXd has demonstrated a manageable and tolerable safety profile across tumor types. We describe a study investigating the efficacy and safety of I-DXd in pts with advanced solid tumors with substantial unmet medical needs. Methods: IDeate-PanTumor02 (NCT06330064) is a global, multicenter, open-label, single-arm, parallel-cohort, Phase 1b/2 study in ~520 adults with recurrent or metastatic solid tumors...