A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT03071757
Last Updated: 2022-04-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
139 participants
INTERVENTIONAL
2017-03-21
2022-04-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors
NCT06158958
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
NCT02391480
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
NCT01478685
A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
NCT02365662
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors
NCT02988960
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1A: Monotherapy Dose Escalation
Part 1A: ABBV-368 (various dose levels) intravenous administration every 2 weeks (Q2W). One cycle of treatment is 28 days, thus there will be 2 doses with ABBV-368 per cycle.
ABBV-368
Intravenous infusion
Part 2A: Monotherapy Cohort Expansion
Part 2A: Additional participants (triple negative breast cancer \[TNBC\]) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W.
ABBV-368
Intravenous infusion
Part 2B: Combination Therapy Cohort Expansion
Part 2B: Additional participants (with Head and Neck carcinoma) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W plus ABBV-181.
ABBV-368
Intravenous infusion
ABBV-181
Intravenous infusion
Part 3A: 18F-AraG Imaging Substudy in TNBC Participants
Part 3A: Additional participants (with TNBC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
ABBV-368
Intravenous infusion
ABBV-181
Intravenous infusion
Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants
Part 3B: Additional participants (with HNSCC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
ABBV-368
Intravenous infusion
ABBV-181
Intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-368
Intravenous infusion
ABBV-181
Intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Part 1 Dose Escalation:
* Participants with advanced or metastatic solid tumors that have exhausted standard treatment for their incurable disease and for whom there is currently no programmed cell death 1 (PD-1)/ programmed cell death-ligand 1 (PD-L1) approved therapy, with immunogenic type tumors such as, but not limited to triple negative breast cancer (TNBC), ovarian cancer, small cell lung cancer, mesothelioma, and cholangiocarcinoma.
* Participants who are refractory to a PD-1/PD-L1 agent, with tumor types such as melanoma, NSCLC, platinum-pretreated head and neck cancer, second line bladder and RCC.
* Part 2A and 2B Cohort Expansion:
* 2A : TNBC ABBV-368 monotherapy cohorts: Subjects with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease.
* 2B : Head and Neck cohort: Participants with recurrent squamous cell head and neck carcinoma that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
* Part 3A and 3B Imaging Substudy:
* 3A: Participants with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease and are treatment naïve to a PD-1/PD-L1 targeting agent.
* 3B: Participants with recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. Participants must be treatment naïve to a PD-1/PD-L1 targeting agent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
* Participants must have immune-related Response Evaluation Criteria for Solid Tumors (iRECIST) evaluable or measurable disease in the PART 1 and measurable disease per iRECIST in PART 2
* Adequate bone marrow, kidney and liver function.
Exclusion Criteria
* Prior treatment with an OX40 targeting agent.
* has known uncontrolled metastases to the central nervous system (CNS).
* History of active autoimmune disorders and other conditions that compromise or impair the immune system.
* Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active hepatitis A, B or C. Subjects who have a history of hepatitis B or C who have documented cures after anti-viral therapy may be enrolled.
* Has received live vaccine within 28 days prior to the first dose of study drug.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Moores Cancer Center at UC San Diego /ID# 201334
La Jolla, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 201342
Sacramento, California, United States
Stanford University /ID# 206949
Stanford, California, United States
Yale University /ID# 207895
New Haven, Connecticut, United States
Carolina BioOncology Institute /ID# 160786
Huntersville, North Carolina, United States
Greenville Hospital System /ID# 160785
Greenville, South Carolina, United States
University of Texas Southwestern Medical Center /ID# 201934
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 160788
San Antonio, Texas, United States
University of Virginia /ID# 212895
Charlottesville, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 160787
Fairfax, Virginia, United States
AP-HM - Hopital de la Timone /ID# 165036
Marseille, Bouches-du-Rhone, France
Centre Leon Berard /ID# 165037
Lyon, Rhone, France
Institut Gustave Roussy /ID# 165035
Villejuif, Val-de-Marne, France
Institut Curie /ID# 165038
Paris, Île-de-France Region, France
National Cancer Center Hospital East /ID# 214530
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 214531
Chuo-ku, Tokyo, Japan
Pan American Center for Oncology Trials, LLC /ID# 213809
Rio Piedras, , Puerto Rico
Hospital Duran i Reynals /ID# 205997
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973
Majadahonda, Madrid, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879
Pamplona, Navarre, Spain
Hospital General Universitario Gregorio Maranon /ID# 205999
Madrid, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 211500
Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 211499
Valencia, , Spain
National Cheng Kung University Hospital /ID# 164002
Tainan City, , Taiwan
National Taiwan University Hospital /ID# 164000
Taipei, , Taiwan
Taipei Medical University Hospital /ID# 164001
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-004205-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-074
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.