A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Acute Myeloid Leukemia (AML); Cancer; Non Small Cell Lung Cancer

Treatments: Drug: ABBV-184

Study type: Interventional

Funder types: Industry

Identifiers

NCT04272203

2019-003434-16 (EudraCT Number)

M19-747

Details and patient eligibility

About

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 (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC.

ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries.

Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time.

There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

Dose Escalation: Participants With AML

Experimental group

Description:

Participants with relapsed or refractory (R/R) AML will receive escalating doses of ABBV-184

Treatment:

Drug: ABBV-184

Dose Escalation: Participants With NSCLC

Experimental group

Description:

Participants with relapsed or refractory (R/R) NSCLC will receive escalating doses of ABBV-184

Treatment:

Drug: ABBV-184

Dose Expansion: Participants With AML

Experimental group

Description:

Participants with R/R AML will receive ABBV-184 at recommended Phase 2 dose (RP2D) determined in dose escalation phase for AML

Treatment:

Drug: ABBV-184

Dose Expansion: Participants With NSCLC

Experimental group

Description:

Participants with R/R NSCLC will receive ABBV-184 at RP2D determined in dose escalation phase for NSCLC

Treatment:

Drug: ABBV-184