RecruitingEarly Phase 1NCT06690476

Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma

A Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma

Sponsor

Peking University

Enrollment

74 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

Summary

This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therapy cohort(IPM514 combined with anti-PD-1 antibody, cisplatin and paclitaxel).The dose escalation and dose expansion stages will include patients with unresectable advanced, recurrent or metastatic ESCC who have failed first-line treatment. After confirming the preliminary safety and effectiveness in the dose escalation and dose expansion stages, a neoadjuvant therapy cohort study will be developed, and resectable ESCC subjects will be included.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called IPM514 for people with esophageal squamous cell carcinoma (a type of cancer in the food pipe) that has continued to grow or become intolerable after standard treatments. The study is assessing how safe the drug is, how the body handles it, and whether it shows any signs of fighting the cancer. **You may be eligible if...** - You are 18 or older - You have confirmed esophageal squamous cell carcinoma - Your cancer has progressed or you could not tolerate at least one prior standard treatment (usually a PD-1 immunotherapy combined with platinum-based chemotherapy) **You may NOT be eligible if...** - You have never received any prior systemic treatment for your cancer - You have cancer that has spread to the brain - You have severe organ problems or active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDose escalation(IPM514 monotherapy)

Drug：IPM514 Intramuscular Injection A total of 7 administrations, including 2 cycles of vaccination with each cycle at QW × 3 doses; there is a 2-weeks interval between the two cycles, then followed by a boost dose 3 weeks after the 2'nd cycle.

DRUGDose expansion (IPM514 combined with tislelizumab)

Drug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration The usage and dosage of the tislelizumab will be based on the drug instructions. IPM514 administration is planned to be concomitant with PD-1 antibody and to be stopped after 9 doses of treatment, while the PD-1 antibody will be continuously administered for a maximum of 1 year.

DRUGNeoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel)

Drug：IPM514 Intramuscular Injection Drug：tislelizumab intravenous administration Drug：cisplatin intravenous administration Drug：paclitaxel intravenous administration In this stage, subjects will receive the treatment of IPM514 combined with Tislelizumab, cisplatin and paclitaxel. All four drugs will be administered once every 3 weeks (± 1 day). IPM514 will be administered for the first time on D0, and Tislelizumab, cisplatin and paclitaxel will be administered for the first time on D3 (the administration order: Tislelizumab - paclitaxel - cisplatin). IPM514 will be administered a total of 3 times, and PD-1 antibody, cisplatin and paclitaxel will all be administered a total of 2 times (that is, IPM514 is administered on D0/D21/D42, and Tislelizumab, paclitaxel and cisplatin are administered on D3/D24).