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

NCT07203898 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IPM514-002
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Adverse Events

  Incidence and severity of adverse events (AEs), immune-related adverse events (irAEs), serious adverse events (SAEs) assessed by NCI-CTCAE v5.0, based on testing results of vital signs, physical examinations, 12-lead ECG and laboratory tests as well as participants reported adverse events.

  From the signing of the ICF through 90 days after the last dose

• PK parameter

  The time to peak (Tmax) will be analyzed by quantitative PCR (qPCR) for mRNA in peripheral blood

  1 hour prior to the first and the sixth dose of IPM514, and 2h(±5min）、6h (±5min), 24h (±30min), 48h(±2h) hours post the first and the sixth dose of IPM514.

• PK parameter

  The maximum concentration (Cmax) will be analyzed by quantitative PCR (qPCR） for mRNA in peripheral blood

  1 hour prior to the first and the sixth dose of IPM514, and 2h(±5min）、6h (±5min), 24h (±30min), 48h(±2h) hours post the first and the sixth dose of IPM514.]

• PK parameter

  The half-life (T1/2) will be analyzed by quantitative PCR (qPCR) for mRNA in peripheral blood

  1 hour prior to the first and the sixth dose of IPM514, and 2h(±5min）、6h (±5min), 24h (±30min), 48h(±2h) hours post the first and the sixth dose of IPM514.

• PK parameter

  The area under the curve (AUC) will be analyzed by quantitative PCR (qPCR) for mRNA in peripheral blood

  1 hour prior to the first and the sixth dose of IPM514, and 2h(±5min）、6h (±5min), 24h (±30min), 48h(±2h) hours post the first and the sixth dose of IPM514.

Secondary Outcomes (5)

• ORR

  up to 49 weeks

• PFS

  up to 49 weeks

• DCR

  up to 49 weeks

• DOR

  up to 49 weeks

• Number Of Participants With Anti-drug Antibodies (ADAs)

  within 1 hour prior to the 1st, 6th and 8th administration of IPM514

Study Arms (1)

IPM514

EXPERIMENTAL

Biological: IPM514

Interventions

IPM514 BIOLOGICAL

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.

IPM514

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, a patient must meet all the following criteria:
• Male or female, aged ≥ 18 years on the day the patient voluntarily agrees to participate in the study.
• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
• Histologically confirmed diagnosis of ESCC.
• Patients' prior systemic therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen and have disease progression confirmed by imaging during or after these treatments.
• NOTE:
• Patients with disease progression that occurs during treatment or within 6 months of cessation of neoadjuvant/adjuvant treatment, this neoadjuvant/adjuvant treatment will be regarded as a line of systemic treatment.
• At least one measurable/evaluable lesion by RECIST v1.1 as determined by local site investigator/radiology assessment within 28 days prior to first dose.
• NOTE: Lesions that have been previously irradiated may be considered evaluable provided there is evidence of disease progression following the completion of radiation therapy.
• The HLA typing is HLA-A\*02:01 and/or HLA-A\*11:01.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• The organ function level in the screening period must meet the following requirements (Laboratory data will not be valid if the patient has received growth factors or blood transfusion for prophylactic use within 7 days before the laboratory testing):
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
• Platelet count （PLT）≥ 100,000 cells/mm3

You may not qualify if:

• Known allergy to the components of the study drug.
• Esophageal squamous cell carcinoma known to be prone to complete obstruction under endoscopy requires interventional therapy to relieve the obstruction.
• After stent implantation in esophagus or trachea, patients who are at high risk of bleeding or perforation due to significant tumor invasion of adjacent organs (aorta or trachea), or who have developed fistulas.
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
• Active leptomeningeal disease or uncontrolled brain metastasis. Patients with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:
• Brain imaging at screening shows no evidence of interim progression, clinically stable for at least 4 weeks and have no evidence of new brain metastases.
• Have measurable and/or evaluable disease outside the CNS.
• No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 14 days prior to first dose.
• No stereotactic radiation or whole-brain radiation within 14 days prior to the first dose.
• With previous history of other malignant tumors, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
• With a local infection or systemic infection which requires systemic antibiotic treatment within 2 weeks prior to the first dose of trial treatment.
• With a history of splenectomy, or congenital asplenia.
• Patients who have had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, have not fully recovered from surgery, or have a surgery planned during the time of trial participation.
• Has active autoimmune disease or history of autoimmune diseases at high risk of relapse.
• NOTE: Patients with following diseases may be enrolled if they meet all other eligibility criteria: controlled type I diabetes, hypothyroidism managed with hormone replacement therapy only, controlled celiac disease, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia), or diseases not expected to recur in the absence of external triggering factors.

Sponsors & Collaborators

• Beijing Immupeutics Medicine Technology Limited: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 2, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09