Clinical Study on Noninvasive Evaluation of Ivonescimab Antibody Distribution and Expression in Esophageal Cancer Patients by 89Zr-AK112 PET Imaging

NCT07440212 | Not Yet Recruiting

• 1 other identifier: 2026034
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

As a humanized bispecific antibody targeting PD-1 and VEGF-A, everolizumab exhibits high specificity for binding PD-1 and VEGF-A in vivo. This critical property was systematically validated in a recent molecular imaging study based on positron emission tomography (PET). The study utilized radiolabeled everolizumab to construct an everolizumab PET probe, enabling non-invasive and dynamic monitoring of drug distribution and targeting behavior in living organisms. The results demonstrated that the PET probe exhibited excellent target tissue enrichment in the HCT-116 colorectal cancer xenograft model. In vivo PET imaging revealed a sustained increase in tumor uptake over time, peaking at 48 hours post-administration at 13.73 ± 0.95% ID/g, indicating strong tumor retention. Blocking experiments (pre-injection of excess everolizumab) significantly reduced tumor uptake to 5.20 ± 0.10% ID/g (P=0.00011), strongly supporting that its in vivo targeting is mediated by PD-1/VEGF-A-specific interactions rather than nonspecific accumulation. At 48 hours, the tumor-to-muscle signal-to-noise ratio (T/M ratio) reached 15.62, with an outstanding target-to-background ratio explaining the superior efficacy and safety of everolizumab. Furthermore, in vitro distribution studies confirmed that the retention levels of this antibody in non-target organs such as the liver and blood were significantly lower than those in tumor tissues, suggesting favorable pharmacokinetic properties that may reduce associated potential toxicity risks. Histopathological analysis (H\&E staining) demonstrated no signs of inflammation, necrosis, or other pathological damage in major organs (including the heart, liver, spleen, and kidneys), indicating that evolocimab exhibits good biocompatibility and tolerable safety characteristics.

Conditions

Esophagus Cancer

Keywords

esophagus cancer; PET; Ivonescimab; PD-1

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy, survival analysis

  sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

  Completed within half year after end of the study

Study Arms (1)

Targeted Ivonescimab PET

Noninvasive PET imaging of 89Zr-AK112 for evaluating its expression and distribution in esophageal cancer patients

Eligibility Criteria

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

Study Population

patients diagnosed with esophageal cancer

You may qualify if:

• \) Patients aged over 18 years with no gender restriction;
• \) Patients diagnosed with esophageal cancer;
• \) Patients eligible for 89Zr-AK112 PET examination;
• \) Written informed consent signed by the subject or their legal guardian.

You may not qualify if:

• \) Patients who have received antitumor therapy prior to PET/CT scanning;
• \) Patients with severe diseases that cannot tolerate PET/CT scanning;
• \) Alternative subjects with contraindications to PET/CT scanning;
• \) Radiation exposure exceeding 50 mSv dose in the past year;
• \) Alternative subjects who underwent major surgery within the past 3 months; those who received experimental drugs or devices (with unclear efficacy or safety) within the past 1 month;
• \) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Xiao Chen, PH .D

CONTACT

15922970174; xiaochen229@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)