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COMPLETED Early Phase 1

PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC

NCT06062602 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2021-07-26
Est. Completion 2022-11-15
Phase Early Phase 1

Sponsor

Presage Biosciences

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06062602

The ClinicalTrials.gov registry entry for NCT06062602 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presage Biosciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06062602 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Louisiana, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06062602?

This trial is sponsored by Presage Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial