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

Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other 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 gastrointestinal tumor and other solid tumor will be evaluated.

Timeline

Start

2022-02-14

Primary completion

2026-12

Completion

2027-12

Publications

• Liu C, Liu D, Ji Y, Sun M, Gao S, Ma X, Zhong D, Zhu J, Cao Y, Qi C, Zhang M, Zhang P, Xue R, Peng Z, Zhou J, Ge S, Lu M, Yuan J, Wang Y, Wang Z, Li J, Zhang X, Zhu Y, Zhu H, Xiao S, Gong J, Shen L, Lu Z. A bispecific antibody-drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2025 Oct;31(10):3485-3491. doi: 10.1038/s41591-025-03792-7. Epub 2025 Jul 10.

Drugs

Indications