JPRN-jRCT2080225199
Terminated
Phase 1
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 sites24 target enrollmentMay 21, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie G.K
- Enrollment
- 24
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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