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]

Phase 1

Terminated

• Conditions: Acute myeloid leukemia (AML) or Non-small cell lung cancer (NSCLC)

• Registration Number: JPRN-jRCT2080225199
• Lead Sponsor: AbbVie G.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: terminated
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>pharmacokinetics<br>pharmacodynamics<br>safety<br>1. Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase)<br>2. Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) Rate (Dose Expansion Phase in Participants With AML)<br>3. Objective Response Rate (ORR) (Dose Expansion Phase in Participants With NSCLC)