A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)
NCT ID: NCT03234712
Last Updated: 2021-05-06
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
62 participants
INTERVENTIONAL
2017-10-10
2021-04-14
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 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 Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients
NCT00551850
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
NCT03071757
A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
NCT02391480
A Study of ABT-414 in Subjects With Solid Tumors
NCT01741727
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-321
ABBV-321 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.
ABBV-321
Intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-321
Intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed solid tumor of one of the following types associated with overexpression of Epidermal Growth Factor Receptor (EGFR). (For Expansion Phase: Subjects must have EGFR overexpression demonstrated by central assessment or Sponsor selected test).
Dose Escalation Phase:
* Colorectal cancer (CRC), Glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), bladder, cervical, esophageal, kidney or sarcoma.
* Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent. Participants must not be eligible for, or has refused further therapy that is likely to provide a survival benefit.
* Must have measureable disease as per RECIST Version 1.1 or RANO (for GBM).
* Minimum life expectancy of at least 12 weeks.
Expansion Phase (Solid Tumor Cohort):
* Histologically or cytologically confirmed advanced solid tumor.
* Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent.
* Must have measureable disease as per RECIST Version 1.1.
* Minimum life expectancy of at least 12 weeks.
Expansion Phase (GBM Cohort Only):
* Participant has recurrent primary (de novo) glioblastoma histologically confirmed at any time from initial diagnosis through latest recurrence.
* Participant has recurrent GBM per Response Evaluation in Neuro-Oncology (RANO) requirements.
* Tumor is measurable according to RANO criteria.
Exclusion Criteria
* New York Heart Association (NYHA) Class III or IV heart failure and/or ejection fraction of \< 40% as measured by echocardiogram at screening.
* Unstable angina pectoris or cardiac ventricular arrhythmia.
* Myocardial infarction or cerebrovascular accident (CVA) within 6 months.
* Documented history of capillary leak syndrome within 6 months of study enrollment.
* Grade 2 or higher peripheral edema, ascites, pleural, or pericardial effusion within 4 weeks of study enrollment or any history of recurrent grade 2 or higher effusions requiring ongoing drainage.
* Active keratitis or current corneal disorder.
* Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
* Major surgery (including opening of the abdomen, chest) within 21 days of the first dose of study drug.
* Uncontrolled metastases from an extracranial solid tumor to the central nervous system (CNS). Participants with brain metastases from an extracranial solid tumor are eligible after definitive therapy provided they are asymptomatic for at least 2 weeks prior to first dose of ABBV-321.
* No history of medical condition resulting in nephrotic range proteinuria.
* Participants must not have been treated in anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy, biologic therapy or investigational anti-cancer therapy within a period of 21 days or herbal anticancer therapy within 7 days prior to the first dose of study drug.
* For approved targeted small molecules, a washout period of 5 half-lives is adequate (no washout period required for subjects currently on erlotinib)
* Participant must not have been in more than three lines of systemic cytotoxic therapy (excluding adjuvant and neoadjuvant therapy)
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.
Highlands Oncology Group /ID# 166132
Springdale, Arkansas, United States
The Angeles Clinic and Researc /ID# 166133
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 215012
Sacramento, California, United States
Northwestern University Feinberg School of Medicine /ID# 165191
Chicago, Illinois, United States
University of Chicago /ID# 166064
Chicago, Illinois, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 201095
Skokie, Illinois, United States
University of Kentucky Markey Cancer Center /ID# 217665
Lexington, Kentucky, United States
Dana-Farber Cancer Institute /ID# 212920
Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 214955
St Louis, Missouri, United States
Columbia Univ Medical Center /ID# 167184
New York, New York, United States
Stony Brook University Hospital /ID# 216976
Stony Brook, New York, United States
Duke University Medical Center /ID# 166135
Durham, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 168600
Providence, Rhode Island, United States
South Texas Accelerated Research Therapeutics /ID# 166134
San Antonio, Texas, United States
Northern Cancer Institute /ID# 166138
St Leonards, New South Wales, Australia
Monash Health /ID# 217435
Clayton, Victoria, Australia
Austin Hospital /ID# 166137
Heidelberg, Victoria, Australia
Sheba Medical Center /ID# 166398
Ramat Gan, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Carneiro BA, Papadopoulos KP, Strickler JH, Lassman AB, Waqar SN, Chae YK, Patel JD, Shacham-Shmueli E, Kelly K, Khasraw M, Bestvina CM, Merrell R, Huang K, Atluri H, Ansell P, Li R, Jin J, Anderson MG, Reilly EB, Morrison-Thiele G, Patel K, Robinson RR, Aristide MRN, Gan HK. Phase I study of anti-epidermal growth factor receptor antibody-drug conjugate serclutamab talirine: Safety, pharmacokinetics, and antitumor activity in advanced glioblastoma. Neurooncol Adv. 2022 Dec 21;5(1):vdac183. doi: 10.1093/noajnl/vdac183. eCollection 2023 Jan-Dec.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M16-438
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.