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Completed Phase 1 Interventional

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

ClinicalTrials.gov ID: NCT04196283

Public ClinicalTrials.gov record NCT04196283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Study identification

NCT ID
NCT04196283
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
AbbVie
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 22, 2020 (Actual)
Primary completion
Oct 27, 2022 (Actual)
Completion
Oct 27, 2022 (Actual)
Last update posted
Feb 27, 2023

2020 – 2022

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
The University of Chicago Medical Center /ID# 217196 Chicago Illinois 60637-1443 —
Norton Cancer Institute /ID# 216179 Louisville Kentucky 40241-2832 —
Barbara Ann Karmanos Cancer In /ID# 214050 Detroit Michigan 48201 —
Nebraska Methodist Hospital /ID# 215786 Omaha Nebraska 68114 —
Atlantic Health System /ID# 216159 Morristown New Jersey 07960-6136 —
Roswell Park Comprehensive Cancer Center /ID# 215882 Buffalo New York 14263 —
Vanderbilt Ingram Cancer Center /ID# 214040 Nashville Tennessee 37232-0021 —
MD Anderson Cancer Center /ID# 214041 Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04196283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 27, 2023 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04196283 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →