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
NCT ID: NCT04196283
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-01-22
2022-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1: ABBV-368 + Tilsotolimod
Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
ABBV-368
Intravenous (IV) infusion
Tilsotolimod
Intratumoral (IT) injection
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.
ABBV-368
Intravenous (IV) infusion
Tilsotolimod
Intratumoral (IT) injection
Nab-paclitaxel
Intravenous (IV) infusion
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.
ABBV-368
Intravenous (IV) infusion
Tilsotolimod
Intratumoral (IT) injection
Nab-paclitaxel
Intravenous (IV) infusion
ABBV-181
Intravenous (IV) infusion
Interventions
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ABBV-368
Intravenous (IV) infusion
Tilsotolimod
Intratumoral (IT) injection
Nab-paclitaxel
Intravenous (IV) infusion
ABBV-181
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Idera Pharmaceuticals, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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The University of Chicago Medical Center /ID# 217196
Chicago, Illinois, United States
Norton Cancer Institute /ID# 216179
Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer In /ID# 214050
Detroit, Michigan, United States
Nebraska Methodist Hospital /ID# 215786
Omaha, Nebraska, United States
Atlantic Health System /ID# 216159
Morristown, New Jersey, United States
Roswell Park Comprehensive Cancer Center /ID# 215882
Buffalo, New York, United States
Vanderbilt Ingram Cancer Center /ID# 214040
Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 214041
Houston, Texas, United States
Centre Antoine Lacassagne - Nice /ID# 215706
Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 215657
Marseille, Bouches-du-Rhone, France
Hopital Saint-Andre /ID# 215702
Bordeaux, Gironde, France
Institut Curie /ID# 215653
Paris, Île-de-France Region, France
Universitaetsklinikum Erlangen /ID# 214196
Erlangen, Bavaria, Germany
Universitaetsklinikum Leipzig /ID# 214200
Leipzig, Saxony, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
Berlin, , Germany
The Chaim Sheba Medical Center /ID# 215229
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 215231
Haifa, , Israel
Gastroenterology Institute, Division of Medicine /ID# 215862
Jerusalem, , Israel
Antoni van Leeuwenhoek /ID# 215291
Amsterdam, North Holland, Netherlands
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Fuenlabrada /ID# 214263
Fuenlabrada, Madrid, Spain
Hospital Clinic de Barcelona /ID# 214264
Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 214198
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 214110
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 214109
Málaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 221401
Valencia, , Spain
Countries
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Other Identifiers
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2019-003167-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-894
Identifier Type: -
Identifier Source: org_study_id
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