FDA022-BB05 / Shanghai Fudan-Zhangjiang - LARVOL DELTA

Preliminary efficacy and safety of FDA022-BB05 in advanced/metastatic HER2 low breast cancer: Results from a phase II study (ESMO Asia 2025) - P2 | "FDA022-BB05 demonstrated notable antitumor activity and a manageable safety profile in pts with heavily pretreated HER2-low breast cancer. These findings support further clinical development of FDA022-BB05 in this population. References [1] J Med Chem."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor

A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors (clinicaltrials.gov) - P1 | N=107 | Recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: May 2025 ➔ Nov 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Metastases • New P2 trial • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor

A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors (clinicaltrials.gov) - P1 | N=107 | Not yet recruiting | Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

New P1 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor