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
- Conditions
- Advanced Solid Tumors Cancer
- Interventions
- Registration Number
- NCT04196283
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1: ABBV-368 + Tilsotolimod ABBV-368 Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol. Arm 1: ABBV-368 + Tilsotolimod Tilsotolimod Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol. Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel ABBV-368 Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol. Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel Tilsotolimod Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol. Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel Nab-paclitaxel Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol. Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 ABBV-368 Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol. Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 Tilsotolimod Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol. Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 Nab-paclitaxel Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol. Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 ABBV-181 Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
- Primary Outcome Measures
Name Time Method Time to Maximum Serum Concentration (Tmax) of ABBV-368 Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Time to Maximum Serum Concentration (Tmax) of ABBV-368
Change in Clinical Laboratory Test Results 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.
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) Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only) Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Maximum Observed Serum Concentration (Cmax) of ABBV-181
Change in Vital Signs 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.
Terminal-Phase Elimination Rate Constant (β) of ABBV-368 Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Terminal Half-Life (t1/2) of Tilsotolimod Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal Half-Life (t1/2) of Tilsotolimod
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only) 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)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only) Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only) Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal Half-Life (t1/2) of ABBV-181
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) Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Maximum Plasma Concentration (Cmax) of Tilsotolimod Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Number of Participants with Adverse Events (AEs) 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.
Maximum Observed Serum Concentration (Cmax) of ABBV-368 Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Maximum Serum Concentration (Cmax) of ABBV-368
Terminal Half-Life (t1/2) of ABBV-368 Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Terminal Half-Life (t1/2) of ABBV-368
Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only) Cycle 1 through Cycle 3 (each cycle is approximately 28 days) Time to Maximum Serum Concentration (Tmax) of ABBV-181
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) 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.
Objective Response Rate (ORR) 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.
Time to Response (TTR) 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.
Clinical Benefit Rate (CBR) 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)
Progression Free Survival (PFS) 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.
Trial Locations
- Locations (26)
The University of Chicago Medical Center /ID# 217196
🇺🇸Chicago, Illinois, United States
MD Anderson Cancer Center /ID# 214041
🇺🇸Houston, Texas, United States
Norton Cancer Institute /ID# 216179
🇺🇸Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer In /ID# 214050
🇺🇸Detroit, Michigan, United States
Atlantic Health System /ID# 216159
🇺🇸Morristown, New Jersey, United States
Hospital Universitario Virgen de la Victoria /ID# 214109
🇪🇸Malaga, Spain
Universitaetsklinikum Erlangen /ID# 214196
🇩🇪Erlangen, Bayern, Germany
Hospital Universitario de Fuenlabrada /ID# 214263
🇪🇸Fuenlabrada, Madrid, Spain
The Chaim Sheba Medical Center /ID# 215229
🇮🇱Ramat Gan, Tel-Aviv, Israel
Hopital Saint-Andre /ID# 215702
🇫🇷Bordeaux, Gironde, France
Rambam Health Care Campus /ID# 215231
🇮🇱Haifa, Israel
Universitaetsklinikum Leipzig /ID# 214200
🇩🇪Leipzig, Sachsen, Germany
Hospital Clinico Universitario de Valencia /ID# 221401
🇪🇸Valencia, Spain
Gastroenterology Institute, Division of Medicine /ID# 215862
🇮🇱Jerusalem, Israel
Nebraska Methodist Hospital /ID# 215786
🇺🇸Omaha, Nebraska, United States
Vanderbilt Ingram Cancer Center /ID# 214040
🇺🇸Nashville, Tennessee, United States
Centre Antoine Lacassagne - Nice /ID# 215706
🇫🇷Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 215657
🇫🇷Marseille CEDEX 05, Bouches-du-Rhone, France
Institut Curie /ID# 215653
🇫🇷Paris CEDEX 05, Ile-de-France, France
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
🇩🇪Berlin, Germany
Hospital Universitario 12 de Octubre /ID# 214198
🇪🇸Madrid, Spain
Antoni van Leeuwenhoek /ID# 215291
🇳🇱Amsterdam, Noord-Holland, Netherlands
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona /ID# 214264
🇪🇸Barcelona, Spain
Hospital Universitario HM Sanchinarro /ID# 214110
🇪🇸Madrid, Spain
Roswell Park Comprehensive Cancer Center /ID# 215882
🇺🇸Buffalo, New York, United States