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Intratumoral Microdosing of TAK-981 in Head and Neck Cancer

NCT04065555 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-07-29

No results posted yet for this study

Summary

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of TAK-981 and TAK-981 combined with cetuximab or avelumab when administered intratumorally in microdose quantities via the CIVO device. CIVO stands for comparative in vivo oncology.

Conditions

Interventions

DRUG

TAK-981

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Cetuximab

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Avelumab

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

TAK-981 + Cetuximab

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

TAK-981 + Avelumab

Intratumoral microdose injection by the CIVO device.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director · Presage Biosciences

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
2020-10-07
Primary Completion
2022-06-20
Completion
2022-07-20
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 NCT04065555 on ClinicalTrials.gov