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NCT05858229 · ClinicalTrials.gov registry record · Phase 1
Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.
A Phase 1 study of Squamous Cell Carcinoma and RP1, sponsored by Sherrif Ibrahim.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05858229: Active Phase 1 study of Squamous Cell Carcinoma and RP1, sponsored by Sherrif Ibrahim.
NCT05858229 is a Phase 1 study of Squamous Cell Carcinoma and RP1 that is active but no longer recruiting, run by Sherrif Ibrahim. The registered enrollment target is 12 participants, below the 104-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05858229, a Phase 1 study of Squamous Cell Carcinoma and RP1, is active but no longer recruiting, sponsored by Sherrif Ibrahim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC. The enrollment of patients with CSCC will determine study duration.
Primary Outcome
The proportion of patients with pathologic complete response (pCR) per Immune-Related Pathologic Response Criteria' (irPRC) criteria: 0% residual viable tumor (RVT)\] remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery.
Conditions Studied
Interventions
- DRUG RP1
Study Locations (1)
New York
- Rochester Dermatologic Surgery - Victor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What the registry record for NCT05858229 still lists
NCT05858229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 104-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which RP1 is the first listed.
NCT05858229 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05858229 about?
NCT05858229 is a clinical study titled "Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.". This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous soli...
What is the current status of trial NCT05858229?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-06-16. Estimated completion is 2026-06.
What conditions does trial NCT05858229 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, RP1.
What interventions are being tested in trial NCT05858229?
The interventions under investigation include: RP1 (DRUG).
Who is sponsoring clinical trial NCT05858229?
This trial is sponsored by Sherrif Ibrahim, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05858229 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05858229's enrollment target sits among peer trials
12 44th of 47 higher than 3 of 47 other Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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