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NCT07335380 · ClinicalTrials.gov registry record · Phase 1
Lattice-Based Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma
A Phase 1 study, sponsored by NYU Langone Health.
- Not yet
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07335380 is a Phase 1 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 30 participants.
The verdict
NCT07335380, a Phase 1 study, has not yet begun recruiting, sponsored by NYU Langone Health.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme. Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants. Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until ≈ 30 evaluable subjects (Parts 1 + 2 combined). Patients receive peaks to the primary tumor alone (Group A) or to the primary + involved nodes (Group B) at the investigators' discretion (non-random). Surgery occurs 6-8 weeks after RT; adjuvant therapy is pathology-driven.
Interventions
- DRUG Chemotherapy
- RADIATION Lattice Radiotherapy (LRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-04 |
| Est. Completion | 2031-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07335380
The ClinicalTrials.gov registry entry for NCT07335380 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chemotherapy is the first listed.
NCT07335380 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07335380 about?
NCT07335380 is a clinical study titled "Lattice-Based Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma". Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme. Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants. ...
What is the current status of trial NCT07335380?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-04. Estimated completion is 2031-03.
What interventions are being tested in trial NCT07335380?
The interventions under investigation include: Chemotherapy (DRUG), Lattice Radiotherapy (LRT) (RADIATION).
Who is sponsoring clinical trial NCT07335380?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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