A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.

Timeline

Start

2021-11-29

Primary completion

2026-12

Completion

2027-12

Publications

• Hong SD, Wang YS, Zhao HY, Zhao YY, Wang QM, Ma YX, Li YS, Huang Y, Yang YP, Fu ZM, Chen LK, Zhou F, Yang J, Li XY, Hou X, Zhou NN, Sun LH, Zhang GF, Cui JW, Wu L, Chen G, Zhang YX, Wang HY, Lv DQ, Shi JH, Jiang B, Li C, Li XL, Tang KJ, Yu Y, Ji YH, He ZY, Zhu Y, Zhu H, Xiao S, Zhou CC, Zhang L, Fang WF. Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials. Ann Oncol. 2026 Jun;37(6):813-824. doi: 10.1016/j.annonc.2026.01.009. Epub 2026 Jan 27.
• Ma Y, Huang Y, Zhao Y, Zhao S, Xue J, Yang Y, Fang W, Guo Y, Han Y, Yang K, Li Y, Yang J, Fu Z, Chen G, Chen L, Zhou N, Zhou T, Zhang Y, Zhou H, Liu Q, Zhu Y, Zhu H, Xiao S, Zhang L, Zhao H. BL-B01D1, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study. Lancet Oncol. 2024 Jul;25(7):901-911. doi: 10.1016/S1470-2045(24)00159-1. Epub 2024 May 29.

Drugs

Indications

No indication recorded.