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

NCT04272203

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: M19-747
  • SECONDARY ID: 2019-003434-16
  • NCT ID: NCT04272203

Conditions

  • Acute Myeloid Leukemia (AML)
  • Non Small Cell Lung Cancer
  • Cancer

Interventions

DrugSynonymsArms
ABBV-184Dose Escalation: Participants With AML

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation: Participants With AMLExperimentalParticipants with relapsed or refractory (R/R) AML will receive escalating doses of ABBV-184
  • ABBV-184
Dose Escalation: Participants With NSCLCExperimentalParticipants with relapsed or refractory (R/R) NSCLC will receive escalating doses of ABBV-184
  • ABBV-184
Dose Expansion: Participants With AMLExperimentalParticipants with R/R AML will receive ABBV-184 at recommended Phase 2 dose (RP2D) determined in dose escalation phase for AML
  • ABBV-184
Dose Expansion: Participants With NSCLCExperimentalParticipants with R/R NSCLC will receive ABBV-184 at RP2D determined in dose escalation phase for NSCLC
  • ABBV-184

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of acute myeloid leukemia (AML) or non-small cell lung cancer (NSCLC).

          -  Participant must weigh at least 35 kilograms (kg).

          -  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 known oncogenic
                  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase)
Time Frame:Up to 1 Cycle after the last participant is enrolled in dose escalation phase (Approximately 2 years)
Safety Issue:
Description:The RP2D of ABBV-184 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.

Secondary Outcome Measures

Measure:Change in Montreal Cognitive Assessment (MoCA)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:The Montreal Cognitive Assessment (MoCA) is a one page 30-point written test that assesses cognitive function.
Measure:Maximum Observed Serum Concentration (Cmax) of ABBV-184
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Maximum Serum Concentration (Cmax) of ABBV-184.
Measure:Time to Maximum Observed Serum Concentration (Tmax)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Time to Maximum Serum Concentration (Tmax) of ABBV-184.
Measure:Terminal Phase Elimination Rate Constant (β) for ABBV-184
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Terminal Phase Elimination Rate Constant (β) for ABBV-184.
Measure:Terminal Phase Elimination Half-life (t1/2) of ABBV-184
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Terminal Phase Elimination Half-life (t1/2) of ABBV-184.
Measure:Area Under the Serum Concentration-Time Curve of ABBV-184
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Area Under the Serum Concentration-Time Curve of ABBV-184.
Measure:Percentage of Participants With Anti-drug Antibodies (ADAs)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Percentage of Participants With Anti-drug Antibodies (ADAs)
Measure:Duration of Response (DOR) (Dose Expansion Phase)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever occurs first.
Measure:Progression-free Survival (PFS) (Dose Expansion Phase)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:PFS will be defined as the time between the first dose of any study drug and the first occurrence of progression or death from any cause.
Measure:Relapse-Free Survival (RFS) (Dose Expansion Phase in Participants With AML)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:RFS is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever occurs first.
Measure:Change in Bone Marrow Blast Count (Dose Expansion Phase in Participants With AML)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Percentage of blast cells in bone marrow.
Measure:Change in Peripheral Blood Blast Count (Dose Expansion Phase in Participants With AML)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:Percentage of blast cells in peripheral blood.
Measure:Objective Response Rate (ORR) (Dose Expansion Phase in Participants With AML)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:ORR is defined as the proportion of participants with complete remission (CR), morphologic complete remission with incomplete blood count recovery (CRi), complete remission with partial hematologic recovery (CRh), complete response with incomplete platelet recovery (CRp), and partial remission (PR).
Measure:Rate of Conversion to Transfusion Independence (Dose Expansion Phase in Participants With AML)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:AML participants will be considered to have converted to transfusion independence if they receive no red blood cell transfusion, platelet transfusion, or growth factors for a 56-day window after beginning study treatment.
Measure:Clinical Benefit Rate (CBR) (Dose Expansion Phase in Participants With NSCLC)
Time Frame:Up to 30 days after last participant complete study drug (Approximately 3 years)
Safety Issue:
Description:CBR is defined as the proportion of participants with a CR, PR, or stable disease (SD) for at least 6 weeks by RECIST 1.1 criteria.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Advanced Solid Tumors Cancer
  • Acute Myeloid Leukemia (AML)
  • Non Small Cell Lung Cancer (NSCLC)
  • Blood Cancer
  • ABBV-184
  • Cancer

Last Updated

February 14, 2020