The study LCCC2215: PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC with Residual Disease requires pharmaceutical labeling and distribution of Datopotamab-deruxtecan (Dato-DXd, DS-1062a) at six (6) trial sites in the United States, with an anticipated study start date of October 2025. Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) produced by Daiichi Sankyo that has demonstrated promising efficacy in breast cancer patients with a manageable safety profile. Dato-DXd, DS-1062a will be shipped from Daiichi Sankyo’s Germany facility in the following two manners: 1) For Injection: 50mg/2.5mL frozen liquid drug product [FLDP]): 50 mg of DS-1062a in 2.5 mL solution (20 mg/mL) in a single-use vial, and 2) For Injection 100 mg (Lyophilized-Drug Product [Lyo-DP]): 100 mg of DS-1062a in lyophilized powder dosage form in a single-use vial to be reconstituted with 5 mL of water for injection to 20 mg/mL. Transport and storage conditions are provided by Daiichi Sankyo and included in ATTACHMENT H: Transport and Storage Conditions DS-1062a. A total of 15 patients will receive treatment at 6 mg/kg IV every 3 weeks for 8 cycles. The most economical amount of drug should be included with each shipment. Awarded vendor will be required to label the investigational drug and will need to quote for supply chain management. Awarded vendor will not be required to create a randomization code for the trial or destroy unused drug from sites at study close.
