NCT07440212Not yet recruiting
Clinical Study on Noninvasive Evaluation of Ivonescimab Antibody Distribution and Expression in Esophageal Cancer Patients by 89Zr-AK112 PET Imaging
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07440212
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Feb 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\) Patients who have received antitumor therapy prior to PET/CT scanning;
- 4\) Radiation exposure exceeding 50 mSv dose in the past year;
- 5\) 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;
- 6\) Alternative subjects with any clinical conditions that the principal investigator of this study considers may cause or pose potential hazards from the investigational product.
Other illness
- 2\) Patients with severe diseases that cannot tolerate PET/CT scanning;
Other
- 3\) Alternative subjects with contraindications to PET/CT scanning;
Who the study is looking for
- 1\) Patients aged over 18 years with no gender restriction;
- 2\) Patients diagnosed with esophageal cancer;
- 3\) Patients eligible for 89Zr-AK112 PET examination;
- 4\) Written informed consent signed by the subject or their legal guardian.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daping Hospital, Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.