Clinical trial · Interventional
Study of the Safety of KSP Heptapeptide (KSP-910638G)
Study of the Safety of KSP Heptapeptide (KSP-910638G) in Humans for the Early Detection of GI Malignancies
NCT03161418CI-TRIAL-00030680completedPhase 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)
The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial growth factor receptor 2 (HER2).
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-910638G, 0.4 mg | Drug | — | UNRESOLVED |
| KSP-910638G, 1.2 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KSP-910638G 0.4 mg subjects 1-3
- description
- The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.4 mg of KSP-910638G total. For the first three subjects, 3.34 mL of KSP-910638G will be discarded. The 1.66 mL of KSP-910638G remaining in the syringe will be administered by squirting it into the mouth of the subject.
- interventionNames
- Drug: KSP-910638G, 0.4 mg
- type
- EXPERIMENTAL
- label
- KSP-910638G 1.2 mg subjects 4-25
- description
- Following a safety review of the first three subjects receiving 0.4 mg dose, the remaining 22 subjects will receive the full 1.2 mg dose of KSP-910638G 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
- Drug: KSP-910638G, 1.2 mg
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 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.