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

NCT07203898 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Immupeutics Medicine Technology Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07203898 on ClinicalTrials.gov