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A phase 1, first in human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid

11 Nov, 2022

Authors:

Anthony Tolcher1, Nashat Gabrail2, Minal Barve3, Xiaohua Wu4, Jian Zhang4, Michael Shi5, Chuan Qi5, Lei Chen5, Steven Yu5, Jenny Yao5, Jianming Wang5, Christopher T. Cavanaugh5

1NEXT Oncology, San Antonio, TX, USA; 2Gabrail Cancer, Canton, OH USA; 3Mary Crowley Cancer Research Centers, Dallas TX, USA; 4Fudan University Shanghai Cancer Center, Shanghai, P. R. China; 5Suzhou Transcenta Therapeutics Co., Ltd, Suzhou, Jiangsu, P. R. China

Background:

Anti-programmed death 1 / ligand 1 (PD-1/PD-L1) therapies have been established as standard treatment for multiple tumor types.However,the key challenge of these therapies is resistance caused by immunosuppressive factors in the tumor microenvironment (TME). TGF-β is a multi-functional cytokine that is involved in the tight regulation of either antitumor immunity or tumor immunosuppression. TGF-β promotes an immune exclusion TME thus renders PD-L1 blockade ineffective. Therefore, dual targeting PD-L1 and TGF-β represents a rational synergistic strategy to enhance clinical outcome relative to each agent alone.

 

TST005 is a novel bi-functional fusion protein combining a high affinity PD-L1 monoclonal antibody (mAb) in a fragment crystallizable (Fc) silenced immunoglobulin G1 (IgG1) backbone and a differentiated transforming growth factor beta (TGF-β) trap with improved stability. This study will investigate TST005's safety, tolerability and preliminary anti-tumor activity in solid tumors.

Study Status:

This study is ongoing at 4 sites in the US and China. As of the 24 Aug 2022, the first three dose cohorts has been completed the evaluation and no DLT was observed. Clinical trial information: NCT04958434. Study Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

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