A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects with Previously Treated Cancers [M19-747]

AbbVie G.K0 个研究点目标入组 24 人开始时间: 2020年5月21日最近更新: 2023年10月17日

试验速览

暂无简介。

•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 have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
•- Laboratory values and cardiac function must meet the protocol specifications.

•- 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.

发起方

AbbVie G.K