717MO - SHR-A1921 in platinum-resistant ovarian cancer (PROC): data from a first-in-human (FIH) phase I study

Background

SHR-A1921 is an ADC composed of a humanized anti-TROP-2 IgG1 mAb attached to a DNA topoisomerase I inhibitor via a tetrapeptide-based cleavable linker. The FIH study of SHR-A1921 showed manageable safety and encouraging anti-tumor activity in patients (pts) with advanced solid tumors. Here, we present the results in PROC pts.

Methods

Pts with PROC (defined as platinum-free interval [PFI] <6 mo) were enrolled, regardless of TROP-2 expression status. Two tolerable dose levels, 3.0 mg/kg (D1, Q3W) and 2.0+2.0 mg/kg (D1 and D8, Q3W), were selected for dose optimization.

Results

As of Mar 20, 2024, 46 PROC pts were enrolled (3.0 mg/kg, n=26; 2.0+2.0 mg/kg, n=20). 39.1% of pts were identified with primary platinum resistance (defined as PFI

Conclusions

SHR-A1921 demonstrated promising efficacy with a manageable safety profile in heavily pretreated pts with PROC. A pivotal phase 3 study is currently in preparation.

Clinical trial identification

NCT05154604. Release date: Dec 13, 2021.

Editorial acknowledgement

Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

Y. Wu, Z. Lin, Z. Zhang, S. Wang: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.