A Study of IPM514 in Patients With Esophageal Squamous Cell Carcinoma.

Summary

This is a Phase 1, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. IPM514 will be administered by intramuscular injection. Six ascending dose cohorts of IPM514 will be evaluated, with each cohort planned to enroll 3-6 qualified participants after a screening period of up to 28 days, following 3 + 3 study design format, the dose levels are as follows: 50 µg, 100 µg, 200 µg, 300 µg, 450 µg, and 600 µg. It may be adjusted during the dose escalation study based on the emerging data of safety, efficacy, and biological responses upon Safety Monitoring Committee (SMC) approval.

Timeline

Start

2026-06-30

Primary completion

2026-12-31

Completion

2027-06-30

Drugs

Indications