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

February 24, 2023 updated by: AbbVie

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Centre Antoine Lacassagne - Nice /ID# 215706
    • Bouches-du-Rhone
      • Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
        • AP-HM - Hopital de la Timone /ID# 215657
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • Hopital Saint-Andre /ID# 215702
    • Ile-de-France
      • Paris CEDEX 05, Ile-de-France, France, 75248
        • Institut Curie /ID# 215653
  • Germany
      • Berlin, Germany, 12203
        • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 214196
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig /ID# 214200
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 215231
      • Jerusalem, Israel, 91120
        • Gastroenterology Institute, Division of Medicine /ID# 215862
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 215229
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
        • Antoni van Leeuwenhoek /ID# 215291
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona /ID# 214264
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 214198
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro /ID# 214110
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria /ID# 214109
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia /ID# 221401
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada /ID# 214263
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • The University of Chicago Medical Center /ID# 217196
    • Kentucky
      • Louisville, Kentucky, United States, 40241-2832
        • Norton Cancer Institute /ID# 216179
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer In /ID# 214050
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital /ID# 215786
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Atlantic Health System /ID# 216159
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Comprehensive Cancer Center /ID# 215882
    • Tennessee
      • Nashville, Tennessee, United States, 37232-0021
        • Vanderbilt Ingram Cancer Center /ID# 214040
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center /ID# 214041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants should weigh at least 35 kg.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of >= 3 months.
  • Participant have >= 1 lesion accessible for intratumoral injection.

  • Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after <= 3 prior treatment regimens administered in the recurrent or metastatic setting.

    • Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.
    • Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.

Exclusion Criteria:

  • Uncontrolled metastases to the central nervous system (CNS).

    • Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study.
  • Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: ABBV-368 + Tilsotolimod
Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
Drug: ABBV-368
Intravenous (IV) infusion
Drug: Tilsotolimod
Intratumoral (IT) injection
Experimental: Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
Drug: ABBV-368
Intravenous (IV) infusion
Drug: Tilsotolimod
Intratumoral (IT) injection
Drug: Nab-paclitaxel
Intravenous (IV) infusion
Experimental: Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181
Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
Drug: ABBV-368
Intravenous (IV) infusion
Drug: Tilsotolimod
Intratumoral (IT) injection
Drug: Nab-paclitaxel
Intravenous (IV) infusion
Drug: ABBV-181
Intravenous (IV) infusion
Other Names:
  • Budigalimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 2 years following the first dose
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 2 years following the first dose
Change in Vital Signs
Time Frame: Up to approximately 2 years following the first dose
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Up to approximately 2 years following the first dose
Change in Clinical Laboratory Test Results
Time Frame: Up to approximately 2 years following the first dose
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Up to approximately 2 years following the first dose
Maximum Observed Serum Concentration (Cmax) of ABBV-368
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Serum Concentration (Cmax) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of ABBV-368
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Plasma Concentration (Cmax) of Tilsotolimod
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of Tilsotolimod
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Observed Serum Concentration (Cmax) of ABBV-181
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Time to Maximum Serum Concentration (Tmax) of ABBV-181
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)
Time Frame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of ABBV-181
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years following the first dose
ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.
Up to approximately 2 years following the first dose
Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 2 years following the first dose
CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)
Up to approximately 2 years following the first dose
Time to Response (TTR)
Time Frame: Up to approximately 2 years following the first dose
TTR is the time from date of first study drug exposure to the first instance of a complete response (CR) or partial response (PR) as a confirmed response, whichever occurs first.
Up to approximately 2 years following the first dose
Progression Free Survival (PFS)
Time Frame: Up to approximately 2 years following the first dose
PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Up to approximately 2 years following the first dose
Duration of Response (DOR)
Time Frame: Up to approximately 2 years following the first dose
DOR is the time from the participant's initial response (CR or PR as a confirmed response) to disease progression or death, whichever occurs first.
Up to approximately 2 years following the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Idera Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M19-894
  • 2019-003167-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings