Bispecific ADC in Esophageal Cancer Treatment
BL-B01D1 Shows Promise in Advanced Squamous Esophageal Carcinoma
Table of Contents
Updated as of December 19, 2025.
Initial Study Results
Data on patients wiht advanced squamous esophageal carcinoma (ESCC) who experience progression after immunotherapy remains limited. A phase I study evaluated the safety adn effectiveness of BL-B01D1, a first-in-class antibody-drug conjugate consisting of a bispecific EGFR-HER3 antibody linked to a topoisomerase I inhibitor.
The study, conducted by researchers led by Lui Chan from Peking University Cancer Hospital and Institute, included 82 patients previously treated for ESCC. The primary endpoint was to determine the recommended phase II dose.
Dosage and Response Rates
Patients received either 2.0 mg/kg (n=22) or 2.5 mg/kg (n=60) of BL-B01D1 via infusion every three weeks. The confirmed objective response rate (cORR) was 29.3% (24 of 82) across all patients, and 32.9% (24 of 73) for those evaluable.
Specifically, the 2.5 mg/kg group demonstrated a cORR of 39.6% (21 of 53) and a disease control rate of 79.2% (42 of 53). In contrast, the 2.0 mg/kg group had a cORR of 15.0% (3 of 20) and a disease control rate of 50.0% (10 of 20). Based on these findings, researchers established the phase II dose at 2.5 mg/kg administered every three weeks.
Adverse Events
The incidence of grade 3 treatment-emergent adverse events was 63.3% in the 2.5 mg/kg group.Common adverse events included anemia (28.3%), leukopenia (18.3%), thrombocytopenia (18.3%), and neutropenia (16.7%).
Two cases of grade 3 interstitial lung disease were also reported.