Daiichi Sankyo has begun a Phase I trial to evaluate the safety and tolerability of DS-1062 in patients with unresectable advanced non-small cell lung cancer (NSCLC).

The open-label trial will examine DS-1062 in NSCLC patients that are resistant to standard treatment or have relapsed.

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The first part of the trial will study the safety and tolerability of increasing doses of DS-1062 to identify the maximum tolerated dose and recommended dose for expansion. The second part of the study will assess the safety and tolerability of DS-1062 at the recommended dose for expansion.

“With the initiation of this study of DS-1062, we move our third antibody-drug conjugate (ADC) into the clinic and continue to investigate the potential of the smart delivery of chemotherapy in various cancers.”

The trial’s endpoints are safety, pharmacokinetics, objective response rate, duration of response, disease control rate, time to response, progression-free survival, overall survival, biomarker analysis and immunogenicity.

The study aims to enrol roughly 40 patients with unresectable advanced NSCLC in the US and Japan.

Daiichi Sankyo oncology research and development executive vice-president and global head Antoine Yver said: “We are initially focusing on evaluating DS-1062 in patients with advanced NSCLC with potential expansion into other tumour types depending on the results of this early critical test in a study designed to provide evidence supporting unique properties of this particular TROP2 ADC construct.

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“With the initiation of this study of DS-1062, we move our third antibody-drug conjugate (ADC) into the clinic and continue to investigate the potential of the smart delivery of chemotherapy in various cancers, including lung, breast and gastric cancer.”

Daiichi Sankyo’s DS-1062 is an investigational trophoblast cell-surface antigen 2-(TROP2)-targeting ADC.

It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload.