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Acute Myeloid Leukemia (AML)Phase 1NCT04272203

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

A Phase 1 study testing ABBV-184 in people with Acute Myeloid Leukemia (AML) and Non Small Cell Lung Cancer, run by AbbVie at 17 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-184
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
17 sitesin 5 countries
Study dates
5 May 2020to 27 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

France5 sites

  • Hopital Saint-Andre /ID# 224218

    Bordeaux, 33075

  • CHRU Lille - Hopital Claude Huriez /ID# 217508

    Lille, Hauts-de-France, 59037

  • CHU de Nantes, Hotel Dieu -HME /ID# 215703

    Nantes, Pays de la Loire Region, 44000

  • Centre Antoine Lacassagne - Nice /ID# 218014

    Nice, Alpes-Maritimes, 06189

  • CHU Bordeaux - Hopital Haut Leveque /ID# 224998

    Pessac, Gironde, 33604

Other trials in France

United States3 sites

  • Gabrail Cancer Center Research /ID# 215667

    Canton, Ohio, 44718

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332

    Fort Wayne, Indiana, 46804

  • Thomas Jefferson University /ID# 218403

    Philadelphia, Pennsylvania, 19107-4414

Other trials in United States

Israel3 sites

  • Rambam Health Care Campus /ID# 215808

    Haifa, 3109601

  • The Chaim Sheba Medical Center /ID# 215810

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 222749

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Japan3 sites

  • National Cancer Center Hospital /ID# 216466

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 216467

    Kashiwa-shi, Chiba, 277-8577

  • Aichi Cancer Center Hospital /ID# 216469

    Nagoya, Aichi-ken, 464-8681

Other trials in Japan

United Kingdom3 sites

  • Cardiff & Vale University Health Board /ID# 217250

    Cardiff, Wales, CF14 4XN

  • The Christie Hospital /ID# 216118

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Foundation Trust /ID# 217252

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

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

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.

Read more

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.

Being tested
ABBV-184
Keywords
Advanced Solid Tumors Cancer, Acute Myeloid Leukemia (AML), Non Small Cell Lung Cancer (NSCLC), Blood Cancer, ABBV-184, Cancer
Medical subject headings
Leukemia, Myeloid, Acute, Carcinoma, Non-Small-Cell Lung, Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-184Drug

    Intravenous (IV) infusion

Study groups in NCT04272203
Study groupRoleWhat they receive
Dose Escalation: Participants With AMLExperimentalParticipants with relapsed or refractory (R/R) AML will receive escalating doses of ABBV-184
Receives: Drug: ABBV-184
Dose Escalation: Participants With NSCLCExperimentalParticipants with relapsed or refractory (R/R) NSCLC will receive escalating doses of ABBV-184
Receives: Drug: 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
Receives: Drug: ABBV-184
Dose Expansion: Participants With NSCLCExperimentalParticipants with R/R NSCLC will receive ABBV-184 at RP2D determined in dose escalation phase for NSCLC
Receives: Drug: ABBV-184

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase)

    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.

    Measured: Up to 1 Cycle after the last participant is enrolled in dose escalation phase (Approximately 2 years)

  2. Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) Rate (Dose Expansion Phase in Participants With AML)

    CR/CRh rate is assessed based on the Clopper-Pearson (exact) method.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  3. Objective Response Rate (ORR) (Dose Expansion Phase in Participants With NSCLC)

    ORR is defined as participants with confirmed complete or partial response (CR+PR) per RECIST, v1.1

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

Secondary outcomes (20)

  1. Number of Participants with Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  2. Change in Laboratory Parameters

    Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  3. Change in Vital Signs

    Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  4. Change in Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a one page 30-point written test that assesses cognitive function.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  5. Change in Echocardiogram

    Number of participants with abnormal change from baseline in echocardiogram will be reported.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  6. Change in Electrocardiogram (ECG)

    12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  7. Maximum Observed Serum Concentration (Cmax) of ABBV-184

    Maximum Serum Concentration (Cmax) of ABBV-184.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  8. Time to Maximum Observed Serum Concentration (Tmax)

    Time to Maximum Serum Concentration (Tmax) of ABBV-184.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  9. Terminal Phase Elimination Rate Constant (β) for ABBV-184

    Terminal Phase Elimination Rate Constant (β) for ABBV-184.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  10. Terminal Phase Elimination Half-life (t1/2) of ABBV-184

    Terminal Phase Elimination Half-life (t1/2) of ABBV-184.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  11. Area Under the Serum Concentration-Time Curve of ABBV-184

    Area Under the Serum Concentration-Time Curve of ABBV-184.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  12. Percentage of Participants With Anti-drug Antibodies (ADAs)

    Percentage of Participants With Anti-drug Antibodies (ADAs)

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  13. Duration of Response (DOR) (Dose Expansion Phase)

    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.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  14. Progression-free Survival (PFS) (Dose Expansion Phase)

    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.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  15. Relapse-Free Survival (RFS) (Dose Expansion Phase in Participants With AML)

    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.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  16. Change in Bone Marrow Blast Count (Dose Expansion Phase in Participants With AML)

    Percentage of blast cells in bone marrow.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  17. Change in Peripheral Blood Blast Count (Dose Expansion Phase in Participants With AML)

    Percentage of blast cells in peripheral blood.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  18. Objective Response Rate (ORR) (Dose Expansion Phase in Participants With AML)

    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).

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  19. Rate of Conversion to Transfusion Independence (Dose Expansion Phase in Participants With AML)

    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.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

  20. Clinical Benefit Rate (CBR) (Dose Expansion Phase in Participants With NSCLC)

    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.

    Measured: Up to 30 days after last participant complete study drug (Approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start5 May 2020
  3. Primary completion27 Jun 2022
  4. Study completion27 Jun 2022

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272203
Sponsor's protocol ID
M19-747
Other IDs
2019-003434-16, 2019
Status last verified
Sep 2022
First submitted
14 Feb 2020
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peterlin P, Saada-Bouzid E, Moskovitz M, Pigneux A, Yuda J, Sinnollareddy M, Henner WR, Chen D, Freise KJ, Leibman RS, Avigdor A, Shimizu T. First-in-human clinical trial results with ABBV-184, a first-in-class T-cell receptor/anti-CD3 bispecific protein, in adults with previously treated AML or NSCLC. Expert Rev Anticancer Ther. 2024 Sep;24(9):893-904. doi: 10.1080/14737140.2024.2373888. Epub 2024 Jul 10.

    PubMed 38946484

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-184 in people with Acute Myeloid Leukemia (AML) and Non Small Cell Lung Cancer, run by AbbVie at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, United States, Israel, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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