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

NCT06062602 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-06

No results posted yet for this 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.

Conditions

Interventions

DRUG

TAK-676

Intratumoral microdose injection by the CIVO device.

DRUG

Carboplatin

Intratumoral microdose injection by the CIVO device.

DRUG

5-FU

Intratumoral microdose injection by the CIVO device.

DRUG

Paclitaxel

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

TAK-676 + Carboplatin

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

Carboplatin + Paclitaxel

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

Carboplatin + 5-FU

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

TAK-676 + Carboplatin + 5-FU

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

TAK-676 + Carboplatin + Paclitaxel

Intratumoral microdose injection by the CIVO device.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Wendy Jenkins · Presage Biosciences Clinical Development

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2022-11-15
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062602 on ClinicalTrials.gov