trastuzumab biosimilar / Shanghai Fudan-Zhangjiang - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and antitumor activity of FDA022-BB05 in patients with advanced/metastatic solid tumors: A multicenter, open-label, first-in-human, phase I/Ib study (ESMO Asia 2024) - P1 | "Background FDA022-BB05 is an antibody-drug conjugate (ADC) composed of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload, with a high drug-to-antibody-ratio (DAR) of 8. Conclusions FDA022-BB05 has demonstrated a manageable safety profile and quite promising antitumor activity in heavily pretreated HER2 positive BC. The study is still ongoing, while additional indications are being explored through other trials."

Clinical • Metastases • P1 data • PK/PD data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Evaluation of Double Self-Immolative Linker-Based Antibody-Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential. (PubMed, J Med Chem) - "Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials."

Journal • Oncology • CTSB • HER-2