By: IPP Bureau
Last updated : November 14, 2025 11:34 am
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
Daiichi Sankyo has dosed the first patient in a groundbreaking Phase 1 trial of DS3610, an investigational antibody-drug conjugate (ADC) designed to harness the body’s immune system against advanced, metastatic, or unresectable solid tumors.
The trial marks a pivotal step in the company’s mission to develop novel cancer therapies with unique mechanisms of action capable of overcoming resistance to existing immunotherapies and improving patient outcomes.
Despite the availability of various cancer immunotherapies, there remains an unmet need for novel treatment options with distinct mechanisms of action that may overcome resistance to current immunotherapy, enhance tumor responses and delay disease progression in solid tumors.
“By combining precise tumor targeting with an immunotherapy payload, Daiichi Sankyo is exploring a new way to harness the body’s own defenses to attack cancer,” said Ken Takeshita, Global Head, R&D, Daiichi Sankyo. “The initiation of this first-in-human trial of DS3610 represents an important step forward in advancing the next wave of our antibody drug conjugate portfolio and reaffirms our commitment to creating transformative medicines for patients with cancer.”
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events. Pharmacokinetic and immunogenicity endpoints will also be assessed, as well as exploratory efficacy endpoints including objective response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival.
The trial is expected to enroll patients across multiple sites globally, including Asia, Europe and North America, the company said in a release.