5507 Background: BAT8008 is a novel antibody-drug conjugate comprising a TROP-2 antibody and an exatecan payload. Patients with recurrent or metastatic cervical cancer (r/m CC) who have progressed on platinum-based chemotherapy have limited treatment options and poor prognosis. This study reports the safety and efficacy of BAT8008 in a cohort of r/m CC patients from a phase 1 trial. Methods: This analysis is part of BAT-8008-001-CR, a multi-center, open-label phase 1 study with dose escalation and expansion cohorts. Patients with r/m CC who had failed prior systemic treatments were enrolled. BAT8008 was administered 2.4 mg/kg or 2.1mg/kg intravenously every two weeks (Q2W) 2.4 mg/kg. Results: As of Jan 5, 2026, 68 evaluable patients with r/m CC were enrolled (27 at 2.1 mg/kg, 41 at the 2.4 mg/kg). Patients were heavily pre-treated, with 55.9% having received ≥2 prior lines of therapy. 64.7% had prior anti-angiogenic therapy and 38.2% had prior immunotherapy. At the 2.4 mg/kg dose (n=44), the most common TRAEs (any grade/≥G3) were anemia (63.6%/15.9%), WBC decreased (68.2%/25.0%), stomatitis (54.5%/6.8%), and neutrophil count decreased (45.5%/20.5%). No treatment-related deaths occurred. For the RP2D cohort (n=41), the confirmed objective response rate (cORR) was 29.3% and disease control rate (DCR) was 78.0%. The median progression-free survival (mPFS) was 6.7 months (95% CI: 3.5-12.1) and median duration of response (mDoR) was 9.0 months (95% CI: 4.2-12.3). Efficacy was observed across subgroups and was independent of TROP-2 expression level. Conclusions: BAT8008 demonstrated promising and durable anti-tumor activity with a manageable safety profile in heavily pre-treated patients with r/m cervical cancer. These findings support the continued development of BAT8008 in this patient population. Clinical trial information: NCT05620017 . Efficacy Endpoint 2.1 mg/kg (n=27) 2.4 mg/kg (n=41) Overall (n=68) cORR, % (95% CI) 22.2 (10.6-40.8) 29.3 (17.6-44.5) 26.5 (17.4-38.0) DCR, % (95% CI) 81.5 (63.3-91.8) 78.0 (63.3-88.0) 79.4 (68.4-87.3) mPFS, months (95% CI) 5.3 (3.3-8.3) 6.7 (3.5-12.1) 6.5 (3.5-8.3) mDoR, months (95% CI) Not Reached 9.0 (4.2-12.3) 9.0 (5.3-12.3)
Zhao et al. (Wed,) studied this question.