NCT07203898

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

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients With Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC).

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Beijing Immupeutics Medicine Technology Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	IPM514	2 primary immunization cycles: IPM514 will be administered once a week (QW) for 3 consecutive doses per cycle, there will be a 2-week interval between the two cycles. Maintenance treatment: 6 doses administered every 3 weeks (Q3W), and 4 doses administered every 6 weeks (Q6W), if treatment continuously benefit the participant.

Timeline

• Start date: 2026-06-30
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-10-02
• Last updated: 2025-10-02

Regulatory

• FDA-regulated drug study