Junshi Biologics запускает II фазу клинических испытаний инъекционного JS212 для лечения плоскоклеточного рака пищевода

Clinical trial registration and information disclosure platform data show that the open, multi-center Phase II clinical study evaluating the safety and efficacy of JS212 injection combined therapy in patients with advanced esophageal squamous cell carcinoma has been initiated by Shanghai Junshi Biosciences Co., Ltd. The clinical trial registration number is CTR20261087, and the date of first public information is March 26, 2026.

The drug formulation is a sterile powder for injection, administered as an intravenous drip, with a dosage given on the first day of each cycle at a selected dose level. The treatment schedule is every three weeks, continuing until the termination criteria specified in the protocol are met. The main objective of this trial is to evaluate the safety and tolerability of JS212 in combination therapy in patients with advanced esophageal squamous cell carcinoma, to determine the maximum tolerated dose of JS212 in combination therapy, and to assess the recommended dose for Phase III clinical study, as well as to evaluate the objective response rate of JS212 in combination therapy for patients with advanced esophageal squamous cell carcinoma.

JS212 injection is a biological product indicated for esophageal squamous cell carcinoma. Esophageal squamous cell carcinoma is the main subtype of esophageal cancer, originating from the squamous epithelium of the esophagus, with early symptoms being subtle. As the disease progresses, symptoms such as difficulty swallowing may appear, with diagnosis relying on endoscopy and pathological examination, and prognosis for late-stage patients is poor.

The primary endpoints of this trial include safety and tolerability, maximum tolerated dose, recommended dose for Phase III clinical study, and objective response rate; secondary endpoints include other efficacy indicators, blood concentration characteristics, and immunogenicity.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 280 participants.

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Editor: Xiao Lang Kuaibao