The first patient has been dosed in a first-in-human phase 1 trial evaluating DS3610 in patients with advanced, metastatic or unresectable solid tumors.
DS3610 is an investigational STING agonist antibody drug conjugate (ADC) containing an immunomodulatory payload discovered by Daiichi Sankyo (TSE:4568).
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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, MD, 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.”
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About the Phase 1 Trial
The multicenter, open-label, first-in-human phase 1 trial will assess the safety, tolerability, preliminary efficacy and pharmacokinetics of DS3610 in patients with advanced, metastatic or unresectable solid tumors for which no additional standard therapy is available. The dose escalation trial will assess the safety and tolerability of increasing doses of DS3610 to determine the recommended doses for expansion in patients with advanced, metastatic or unresectable solid tumors.
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. For more information, please visit ClinicalTrials.gov.
About DS3610
DS3610 is an investigational STING agonist ADC consisting of a monoclonal antibody with novel Fc modifications attached to an immunomodulatory payload that acts as an agonist of a stimulator of interferon genes (STING). DS3610 delivers a STING agonist payload directly to tumor environments and induces the immune system in the body to target cancer cells.
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Source- businesswire
