Multicenter phase 1 trial of TROP-2-targeting antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors

SHR-A1921 is a novel antibody-drug conjugate targeting TROP-2. A multicenter phase 1 trial in China (NCT05154604) evaluated SHR-A1921 in 391 patients with pretreated advanced or metastic solid tumors. Patients received SHR-A1921 1.5-6.0 mg/kg every 3 weeks. Grade ≥3 treatment-related adverse events occurrred in 33.8%; the most common being stomatitis (14.6%). The incidence of hematologic toxicities was low. The overall response rate was 24.8% (95% CI 20.6-29.4), ranging from 18.2% to 43.1% across cohorts with platinum-resistant ovarian cancer, triple-negative breast cancer, small-cell lung cancer, non-small cell lung cancer, HR-positive breast cancer, cervical cancer, and biliary tract cancer. The dose 3.0 mg/kg every 3 weeks was selected for further clinical development. The authors conclude thatSHR-A1921 demonstrated promising antitumor activity and a manageable safety profile (graphical abstract).