Abstract 5826: RT01: A novel anti-TF, radionuclide drug conjugate (RDC) for theranostic precision oncology

Abstract Tissue Factor (TF) is an attractive therapeutic target for various tumors. We developed RT01, a first-in-class, targeted radio-theranostic agent consisting of a humanized anti-TF antibody conjugated to the diagnostic 89Zr or therapeutic 177Lu radionuclide. In a xenograft tumor model, SPECT/CT imaging demonstrated rapid and specific tumor accumulation of RT01-177Lu (single 200μCi i.v. dose), with retention over 6 days and rapid non-target clearance (background decreased by 4 hours post-injection). The tumor-to-kidney ratio of radiation intensity uptake (%ID/cc) exceeded 9.2. This single 200μCi dose injection of RT01-177Lu demonstrated potent anti-tumor efficacy and excellent tolerability. Histopathology analysis of ten major organs (kidney, intestine, brain, lung, liver, femur, spleen, stomach, heart, and pancreas) revealed no observable abnormalities or serious toxicity. In conclusion, the RT01 theranostic pair provides superior tumor targeting, rapid non-target clearance, and a favorable toxicity profile, supporting its continued clinical development for TF-positive cancers. Citation Format: Yi Zhao, Huahua Hao, Xin Yang, Weiwei Pan, Xinxin Liang, Quanai Zhang, Xiaoxia Liu, Jingting Cui, Elizabeth Wu, Zhican Qu, . RT01: A novel anti-TF, radionuclide drug conjugate (RDC) for theranostic precision oncology [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 5826.