Clinical trial · Interventional
Phase 1A Study of the Safety of KSP/QRH Dimer
Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies
NCT03643068CI-TRIAL-00035639completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety of orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G), a topically administered Li-Cor IRDye800CW labeled heptapeptide dimer (KSP/QRH Dimer) specific for human epithelial growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR).
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 |
|---|---|---|---|
| Healthy Adults | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg | Drug | — | UNRESOLVED |
| KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KSP-QRH-E3-IRDye800 (Peptide 919288G) 0.6 mg subjects 1-3
- description
- The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.6 mg of KSP-QRH-E3-IRDye800 (Peptide 919288G) total. For the first three subjects, 3.34 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)will be discarded. The 1.66 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)remaining in the syringe will be administered by squirting it into the mouth of the subject.
- interventionNames
- Drug: KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg
- type
- EXPERIMENTAL
- label
- KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25
- description
- Following a safety review of the first three subjects receiving 0.6 mg dose, the remaining 22 subjects will receive the full 1.8 mg dose of KSP-QRH-E3-IRDye800 (Peptide 919288G) reconstituted in 5 mL 0.9% NaCl. These 22 subjects will receive all 5 mL of the peptide solution in a syringe for administration. The agent will not be reconstituted until the subject is ready to squirt the peptide into his or her mouth via syringe. They will be asked to wait 5 minutes and then drink at least 4-8 oz of tap water.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Not pregnant (willing to have pregnancy test if applicable) * No recent illness (infection, URI, virus or flu) within 2 weeks, * Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI) * Willing and able to sign informed consent * Willing and able to drink the peptide and a tap water chaser * Willing and able to get baseline and 24-48 hours post ingestion labs * Willing and able to get pre and post ingestion EKG Exclusion Criteria: * Known allergy to li-cor IRDye800CW, a near infrared fluorosphore or derivatives * Subjects on active chemotherapy or radiation therapy * Diabetics on insulin/hypoglycemic (due to fasting requirements)
References
Publications (0)
Data not yet available
No reference posted for this study.