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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 26, 2021

Primary Completion Date

November 15, 2022

Study Completion Date

November 15, 2022

Conditions
Head and Neck Squamous Cell Carcinoma
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.

Trial Locations (4)

10467

Montefiore Medical Center, The Bronx

19107

University of Pennsylvania, Philadelphia

45267

University of Cincinnati Health, Cincinnati

71115

LSU Health Sciences Center - Shreveport, Shreveport

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Presage Biosciences

INDUSTRY

NCT06062602 - PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC | Biotech Hunter | Biotech Hunter