Acute myeloid leukemia (AML) or Non-small cell lung cancer (NSCLC)
Conditions
Interventions
investigational material(s)
Generic name etc : ABBV-184
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
AbbVie G.K
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics safety 1. Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase) 2. Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) Rate (Dose Expansion Phase in Participants With AML) 3. Objective Response Rate (ORR) (Dose Expansion Phase in Participants With NSCLC) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics safety 1. Number of Participants with Adverse Events (AEs) 2. Change in Laboratory Parameters 3. Change in Vital Signs 4. Change in Montreal Cognitive Assessment (MoCA) 5. Change in Echocardiogram 6. Change in Electrocardiogram (ECG) 7. Maximum Observed Serum Concentration (Cmax) of ABBV-184 8. Time to Maximum Observed Serum Concentration (Tmax) 9. Terminal Phase Elimination Rate Constant (beta) for ABBV-184 10. Terminal Phase Elimination Half-life (t1/2) of ABBV-184 11. Area Under the Serum Concentration-Time Curve of ABBV-184 12. Percentage of Participants With Anti-drug Antibodies (ADAs) 13. Duration of Response (DOR) (Dose Expansion Phase) 14. Progression-free Survival (PFS) (Dose Expansion Phase) 15. Relapse-Free Survival (RFS) (Dose Expansion Phase in Participants With AML) 16. Change in Bone Marrow Blast Count (Dose Expansion Phase in Participants With AML) 17. Change in Peripheral Blood Blast Count (Dose Expansion Phase in Participants With AML) 18. Objective Response Rate (ORR) (Dose Expansion Phase in Participants With AML) 19. Rate of Conversion to Transfusion Independence (Dose Expansion Phase in Participants With AML) 20. Clinical Benefit Rate (CBR) (Dose Expansion Phase in Participants With NSCLC) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed