A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers
NCT ID: NCT04272203
Last Updated: 2022-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
14 participants
INTERVENTIONAL
2020-05-05
2022-06-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation: Participants With AML
Participants with relapsed or refractory (R/R) AML will receive escalating doses of ABBV-184
ABBV-184
Intravenous (IV) infusion
Dose Escalation: Participants With NSCLC
Participants with relapsed or refractory (R/R) NSCLC will receive escalating doses of ABBV-184
ABBV-184
Intravenous (IV) infusion
Dose Expansion: Participants With AML
Participants with R/R AML will receive ABBV-184 at recommended Phase 2 dose (RP2D) determined in dose escalation phase for AML
ABBV-184
Intravenous (IV) infusion
Dose Expansion: Participants With NSCLC
Participants with R/R NSCLC will receive ABBV-184 at RP2D determined in dose escalation phase for NSCLC
ABBV-184
Intravenous (IV) infusion
Interventions
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ABBV-184
Intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332
Fort Wayne, Indiana, United States
Gabrail Cancer Center Research /ID# 215667
Canton, Ohio, United States
Thomas Jefferson University /ID# 218403
Philadelphia, Pennsylvania, United States
Centre Antoine Lacassagne - Nice /ID# 218014
Nice, Alpes-Maritimes, France
CHU Bordeaux - Hopital Haut Leveque /ID# 224998
Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 217508
Lille, Hauts-de-France, France
CHU de Nantes, Hotel Dieu -HME /ID# 215703
Nantes, Pays de la Loire Region, France
Hopital Saint-Andre /ID# 224218
Bordeaux, , France
The Chaim Sheba Medical Center /ID# 215810
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 222749
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 215808
Haifa, , Israel
Aichi Cancer Center Hospital /ID# 216469
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 216467
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 216466
Chuo-ku, Tokyo, Japan
Oxford University Hospitals NHS Foundation Trust /ID# 217252
Oxford, Oxfordshire, United Kingdom
Cardiff & Vale University Health Board /ID# 217250
Cardiff, Wales, United Kingdom
The Christie Hospital /ID# 216118
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2019-003434-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-747
Identifier Type: -
Identifier Source: org_study_id
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