By Fineline Cube 
China-based Sino Biopharmaceutical Ltd (HKG: 1177) presented preliminary results from a Phase I clinical study of its TQB2102, an HER2-targeted antibody drug conjugate (ADC), at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated significant efficacy in patients with advanced solid tumors, including those with HER2-positive and HER2-low subtypes who had exhausted standard therapies.
Clinical Trial Results
As of October 1, 2024, 181 patients with advanced solid tumors were enrolled in the study. The results showed an objective response rate (ORR) of 51.3% in patients with HER2-positive breast cancer at the 6mg/kg dose and above. In HER2 low-expressing breast cancer, HER2 high-expressing colorectal cancer, and HER2-positive gastric or gastroesophageal junction adenocarcinoma, the ORR was 51.5%, 34.8%, and 70%, respectively. Notably, in the subgroup of HER2-positive breast cancer patients with brain metastasis, the ORR was 70%, with one case achieving complete intracranial lesion resolution. TQB2102 also demonstrated efficacy in 31% of breast cancer patients who had developed resistance to T-DM1/DS-8201.
Safety Profile
In terms of safety, grade 3 or higher adverse events in the general population primarily included neutropenia (21.7%), decreased white blood cell count (10.6%), anemia (8.9%), and decreased platelet count (6.1%). Only one case (0.55%) of grade 2 interstitial lung disease (ILD) was reported.-Fineline Info & Tech