Back to resultsA 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
Primary Purpose
Advanced Solid Tumors Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-368
Tilsotolimod
Nab-paclitaxel
ABBV-181
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors Cancer focused on measuring Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Cancer
Eligibility Criteria
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).
Sites / Locations
- The University of Chicago Medical Center /ID# 217196
- Norton Cancer Institute /ID# 216179
- Barbara Ann Karmanos Cancer In /ID# 214050
- Nebraska Methodist Hospital /ID# 215786
- Atlantic Health System /ID# 216159
- Roswell Park Comprehensive Cancer Center /ID# 215882
- Vanderbilt Ingram Cancer Center /ID# 214040
- MD Anderson Cancer Center /ID# 214041
- Centre Antoine Lacassagne - Nice /ID# 215706
- AP-HM - Hopital de la Timone /ID# 215657
- Hopital Saint-Andre /ID# 215702
- Institut Curie /ID# 215653
- Universitaetsklinikum Erlangen /ID# 214196
- Universitaetsklinikum Leipzig /ID# 214200
- Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
- The Chaim Sheba Medical Center /ID# 215229
- Rambam Health Care Campus /ID# 215231
- Gastroenterology Institute, Division of Medicine /ID# 215862
- Antoni van Leeuwenhoek /ID# 215291
- Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
- Hospital Universitario de Fuenlabrada /ID# 214263
- Hospital Clinic de Barcelona /ID# 214264
- Hospital Universitario 12 de Octubre /ID# 214198
- Hospital Universitario HM Sanchinarro /ID# 214110
- Hospital Universitario Virgen de la Victoria /ID# 214109
- Hospital Clinico Universitario de Valencia /ID# 221401
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: ABBV-368 + Tilsotolimod
Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181
Arm Description
Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AEs)
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.
Change in Vital Signs
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Change in Clinical Laboratory Test Results
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Maximum Observed Serum Concentration (Cmax) of ABBV-368
Maximum Serum Concentration (Cmax) of ABBV-368
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Terminal Half-Life (t1/2) of ABBV-368
Terminal Half-Life (t1/2) of ABBV-368
Maximum Plasma Concentration (Cmax) of Tilsotolimod
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Terminal Half-Life (t1/2) of Tilsotolimod
Terminal Half-Life (t1/2) of Tilsotolimod
Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)
Maximum Observed Serum Concentration (Cmax) of ABBV-181
Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)
Time to Maximum Serum Concentration (Tmax) of ABBV-181
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)
Terminal Half-Life (t1/2) of ABBV-181
Secondary Outcome Measures
Objective Response Rate (ORR)
ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.
Clinical Benefit Rate (CBR)
CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)
Time to Response (TTR)
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.
Progression Free Survival (PFS)
PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Duration of Response (DOR)
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.
Full Information
NCT ID
NCT04196283
First Posted
December 6, 2019
Last Updated
February 24, 2023
Sponsor
AbbVie
Collaborators
Idera Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04196283
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Idera Pharmaceuticals, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors Cancer
Keywords
Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: ABBV-368 + Tilsotolimod
Arm Type
Experimental
Arm Description
Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
Arm Title
Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel
Arm Type
Experimental
Arm Description
Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
Arm Title
Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181
Arm Type
Experimental
Arm Description
Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
Intervention Type
Drug
Intervention Name(s)
ABBV-368
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Tilsotolimod
Intervention Description
Intratumoral (IT) injection
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
ABBV-181
Other Intervention Name(s)
Budigalimab
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 2 years following the first dose
Title
Change in Vital Signs
Description
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time Frame
Up to approximately 2 years following the first dose
Title
Change in Clinical Laboratory Test Results
Description
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time Frame
Up to approximately 2 years following the first dose
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-368
Description
Maximum Serum Concentration (Cmax) of ABBV-368
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Description
Time to Maximum Serum Concentration (Tmax) of ABBV-368
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Description
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)
Title
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Description
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Terminal Half-Life (t1/2) of ABBV-368
Description
Terminal Half-Life (t1/2) of ABBV-368
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Maximum Plasma Concentration (Cmax) of Tilsotolimod
Description
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Description
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Description
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)
Title
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Description
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Terminal Half-Life (t1/2) of Tilsotolimod
Description
Terminal Half-Life (t1/2) of Tilsotolimod
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)
Description
Maximum Observed Serum Concentration (Cmax) of ABBV-181
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)
Description
Time to Maximum Serum Concentration (Tmax) of ABBV-181
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)
Description
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)
Description
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Title
Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)
Description
Terminal Half-Life (t1/2) of ABBV-181
Time Frame
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.
Time Frame
Up to approximately 2 years following the first dose
Title
Clinical Benefit Rate (CBR)
Description
CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)
Time Frame
Up to approximately 2 years following the first dose
Title
Time to Response (TTR)
Description
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.
Time Frame
Up to approximately 2 years following the first dose
Title
Progression Free Survival (PFS)
Description
PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Time Frame
Up to approximately 2 years following the first dose
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to approximately 2 years following the first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
The University of Chicago Medical Center /ID# 217196
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Norton Cancer Institute /ID# 216179
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241-2832
Country
United States
Facility Name
Barbara Ann Karmanos Cancer In /ID# 214050
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nebraska Methodist Hospital /ID# 215786
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Atlantic Health System /ID# 216159
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center /ID# 215882
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center /ID# 214040
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0021
Country
United States
Facility Name
MD Anderson Cancer Center /ID# 214041
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centre Antoine Lacassagne - Nice /ID# 215706
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
AP-HM - Hopital de la Timone /ID# 215657
City
Marseille CEDEX 05
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Saint-Andre /ID# 215702
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Curie /ID# 215653
City
Paris CEDEX 05
State/Province
Ile-de-France
ZIP/Postal Code
75248
Country
France
Facility Name
Universitaetsklinikum Erlangen /ID# 214196
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 214200
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
The Chaim Sheba Medical Center /ID# 215229
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 215231
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Gastroenterology Institute, Division of Medicine /ID# 215862
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Antoni van Leeuwenhoek /ID# 215291
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada /ID# 214263
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 214264
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 214198
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 214110
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 214109
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 221401
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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