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NCT06062602 · ClinicalTrials.gov registry record · Early Phase 1
PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC
A Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Presage Biosciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 4
- Study locations
NCT06062602: Completed Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by Presage Biosciences.
NCT06062602 is a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma that has completed, run by Presage Biosciences. The registered enrollment target is 15 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06062602, a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma, has completed, sponsored by Presage Biosciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients diagnosed with Head and Neck Squamous Cell Carcinoma presenting with a surface accessible solid tumor for which there is a scheduled surgical intervention. This substudy is a cohort of the PBI-MST-01 Master Protocol.
Primary Outcome
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites in each resected patient sample by IHC and ISH. An aggregate analysis of this quantification may be done across patient samples in each substudy to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to, biomarkers for cell death (e.g., cleaved caspase 3), T-cells (e.g., Cluster of Differentiation 3 (CD3)
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG 5-FU
- DRUG TAK-676
- COMBINATION_PRODUCT TAK-676 + Carboplatin
Study Locations (4)
Louisiana
- LSU Health Sciences Center - Shreveport - Shreveport
New York
- Montefiore Medical Center - The Bronx
Ohio
- University of Cincinnati Health - Cincinnati
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2022-11-15 |
| Phase | Early Phase 1 |
What the finished NCT06062602 record still lists
NCT06062602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06062602 reports a single indexed study location in Louisiana, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT06062602 about?
NCT06062602 is a clinical study titled "PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC". This is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in p...
What is the current status of trial NCT06062602?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2021-07-26. Estimated completion is 2022-11-15.
What conditions does trial NCT06062602 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06062602?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), 5-FU (DRUG), TAK-676 (DRUG), TAK-676 + Carboplatin (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06062602?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06062602 being conducted?
This trial has 4 study locations across Louisiana, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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