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BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic urothelial carcinoma (UC) Background BL-B01D1 is a potentially first-in-class ADC comprised of an EGFR x HER3 bispecific antibody attached to a novel topoisomerase I inhibitor payload (Ed-04) via a tetrapeptide-based cleavable linker. We now present safety/efficacy data from a phase I study of BL-B01D1 in UC. Methods This phase Ib/II study included patients with locally advanced or metastatic urological tumors. The enrolled UC patients were mainly administered at doses of 2.0, 2.5 and 2.75 mg/kg D1D8 Q3W. Results As of Apr 29th, 2024, 32 UC patients were enrolled in Q3W treatment schedule with 29 patients treated at 2.2 mg/kg, 2 patients at 2.5mg/kg and 3 patient at 2.75 mg/kg. The median prior line of systemic treatment was 2 (range, 1-7). Among the enrolled patients, 23 patients dosed at 2.2 mg/kg were evaluable for efficacy, ORR was 43.5% (10/23), cORR was 34.8%
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