A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors

Summary

This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.

Timeline

Start

2020-07-28

Primary completion

2024-08-31

Completion

2024-12-31

Publications

• Wang Y, Xia B, Cao L, Yang J, Feng C, Jiang F, Li C, Gu L, Yang Y, Tian J, Cheng X, Furuuchi K, Fulmer J, Verdi A, Rybinski K, Soto A, Albone E, Uenaka T, Gong L, Liu T, Qin Q, Wei Z, Zhou Y. Preclinical studies of BB-1701, a HER2-targeting eribulin-containing ADC with potent bystander effect and ICD activity. Antib Ther. 2024 Jun 25;7(3):221-232. doi: 10.1093/abt/tbae019. eCollection 2024 Jul.

Drugs

Indications