Clinical trial NCT04196283: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Idera Pharmaceuticals, Inc.
First posted: 2019-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 2 years following the first dose
measure: Change in Vital Signs
timeFrame: Up to approximately 2 years following the first dose
measure: Change in Clinical Laboratory Test Results
timeFrame: Up to approximately 2 years following the first dose
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-368
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Time to Maximum Serum Concentration (Tmax) of ABBV-368
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal-Phase Elimination Rate Constant (β) of ABBV-368
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal Half-Life (t1/2) of ABBV-368
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Maximum Plasma Concentration (Cmax) of Tilsotolimod
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal Half-Life (t1/2) of Tilsotolimod
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
measure: Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)
timeFrame: Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years following the first dose
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 2 years following the first dose
measure: Time to Response (TTR)
timeFrame: Up to approximately 2 years following the first dose
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 2 years following the first dose
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years following the first dose
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 217196
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 216179
state: Kentucky
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer In /ID# 214050
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist Hospital /ID# 215786
state: Nebraska
city: Morristown
country: United States
facility: Atlantic Health System /ID# 216159
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center /ID# 215882
state: New York
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center /ID# 214040
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 214041
state: Texas
city: Nice
country: France
facility: Centre Antoine Lacassagne - Nice /ID# 215706
state: Alpes-Maritimes
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 215657
state: Bouches-du-Rhone
city: Bordeaux
country: France
facility: Hopital Saint-Andre /ID# 215702
state: Gironde
city: Paris CEDEX 05
country: France
facility: Institut Curie /ID# 215653
state: Ile-de-France
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 214196
state: Bayern
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 214200
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 215229
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 215231
city: Jerusalem
country: Israel
facility: Gastroenterology Institute, Division of Medicine /ID# 215862
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek /ID# 215291
state: Noord-Holland
city: Hospitalet de Llobregat
country: Spain
facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402
state: Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada /ID# 214263
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 214264
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 214198
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 214110
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 214109
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 221401
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: