Clinical trial · Interventional
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study had to be terminated for lack of dimer and inability to produce more at this time.
Summary
Brief summary (as posted)
The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope (SFE) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KSP/QRH dimer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Esophagus sprayed with KSP/QRH dimer
- description
- Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe
- interventionNames
- Drug: KSP/QRH dimer
Primary outcomes (4)
- measure
- Binding of KSP/QRH dimer to EGFR and HER2
- timeFrame
- During and immediately after procedure, generally no more than 2 hours
- description
- Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
- measure
- SFE ability to detect dimer by SNR
- timeFrame
- During and immediately after procedure, generally no more than 2 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Has known or suspected Barrett's esophagus * Scheduled for a clinically-indicated, upper endoscopy * Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) * Age 18 to 100 years * Willing and able to sign informed consent Exclusion Criteria: * Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives * Subjects on active chemotherapy or radiation treatment * Pregnant or trying to conceive
References
Publications (1)
- DERIVEDChen J, Jiang Y, Chang TS, Rubenstein JH, Kwon RS, Wamsteker EJ, Prabhu A, Zhao L, Appelman HD, Owens SR, Beer DG, Turgeon DK, Seibel EJ, Wang TD. Detection of Barrett's neoplasia with a near-infrared fluorescent heterodimeric peptide. Endoscopy. 2022 Dec;54(12):1198-1204. doi: 10.1055/a-1801-2406. Epub 2022 Mar 17. PMID 35299273