Status:
TERMINATED
A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers
Lead Sponsor:
AbbVie
Conditions:
Acute Myeloid Leukemia (AML)
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer ...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia (AML) or non-small cell lung cancer (NSCLC).
- Participants must consent to hospitalization for at least 72 hours following the first two doses of ABBV-184 in Cycle 1.
- Participants must have Human Leukocyte Antigen-A2 (HLA-A2) restricted genotype. Participants must be HLA-A2:01 positive in at least one allele tested with a high-resolution HLA genotyping assay performed in a College of American Pathologists (CAP)/Clinical Laboratory Improvement Act (CLIA)-certified or equivalent laboratory.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Laboratory values and cardiac function must meet the protocol specifications.
Exclusion
- For AML participants:
- Presence or history of extramedullary disease are ineligible, participants with a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia are not eligible.
- For NSCLC participants:
- Tumors with epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) gene rearrangements are not eligible.
- Active/uncontrolled central nervous system (CNS) leukemia/lung cancer are not eligible for the study.
- History of inflammatory bowel disease, interstitial lung disease (pneumonitis), myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis, solid organ transplantation, active autoimmune disease (with exceptions of vitiligo, Type I diabetes mellitus, hypothyroidism, and psoriasis), primary immunodeficiency.
- History of clinical diagnosis of tuberculosis or major immunologic reaction to any immunoglobulin G (IgG)-containing agent are not eligible.
- Previously received anti-cancer treatment with an agent that targets the immune system by engaging cluster of differentiation 3 (CD3) are not eligible.
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04272203
Start Date
May 5 2020
End Date
June 27 2022
Last Update
September 8 2022
Active Locations (17)
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1
Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332
Fort Wayne, Indiana, United States, 46804
2
Gabrail Cancer Center Research /ID# 215667
Canton, Ohio, United States, 44718
3
Thomas Jefferson University /ID# 218403
Philadelphia, Pennsylvania, United States, 19107-4414
4
Centre Antoine Lacassagne - Nice /ID# 218014
Nice, Alpes-Maritimes, France, 06189