Daiichi Sankyo and AstraZeneca Initiate Phase I Clinical Trial of Enhertu in Combination with DS-1103a for Solid Tumors

On March 13, Daiichi Sankyo and AstraZeneca registered a Phase I dose-escalation and dose-expansion study on the clinicaltrials.gov website, aiming to evaluate the safety and efficacy of trastuzumab deruxtecan in combination with DS-1103a in patients with solid tumors.

Subjects will receive DS-1103a (starting dose 100mg) and trastuzumab deruxtecan (5.4mg/kg) once every 3 weeks. The primary endpoint of the dose escalation study is the number of subjects experiencing dose-limiting toxicity, while the primary endpoints of the dose expansion study are the number of subjects with adverse events and serious adverse events during treatment, as well as the objective response rate (ORR) assessed by Blinded Independent Central Review (BICR).

The study will begin on April 10, 2023, and is expected to be completed by June 30, 2026. (Click to read the original text for more details on the specific protocol of the study.)

DS-1103a is a monoclonal antibody targeting Signal Regulatory Protein α (SIRPα) developed by Daiichi Sankyo, currently in Phase I research. Globally, 20 SIRPα-targeted drugs have entered clinical stages, with five of them already in Phase II or Phase II/III studies. The SIRPα-Fc fusion protein evorpacept, co-developed by ALX Oncology and Stanford University, is the most advanced, currently in Phase II/III trials. Evorpacept comprises two high-affinity CD47-binding domains from SIRPα and a human immunoglobulin inactive Fc region, where the inactive Fc region has no activity on Fcγ receptors, minimizing the common hematological toxicity associated with CD47 blockers. Additionally, evorpacept exhibits higher penetration in solid tumors, giving it potential for treating solid tumors, which also represents its differential advantage.

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Chinese pharmaceutical companies布局SIRPα靶点include宜明昂科, 石药集团, 信达生物, 礼新医药, among which宜明昂科's IMM01 (SIRPα-Fc fusion protein) and IMM0306 (CD20/SIRPα antibody fusion protein) have both entered Phase II clinical stage, with the fastest progress. 石药集团's JMT601, 盛禾生物's IBC0966, and礼新医药's LM-101 are still in Phase I/II clinical stage.

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