A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
NCT ID: NCT04178902
Last Updated: 2021-07-26
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
8 participants
INTERVENTIONAL
2020-05-19
2021-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: ABBV-467 Dose Escalation
ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
ABBV-467
Intravenous (IV) Infusion
Part B: ABBV-467 Dose Expansion
ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
ABBV-467
Intravenous (IV) Infusion
Interventions
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ABBV-467
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* Measurable disease defined as at least 1 of the following:
* Serum monoclonal protein \>= 1g/dL.
* Urine M-protein \>= 200mg/24 hours.
* Serum immunoglobulin free light chain (FLC) \>= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
* Relapsed after or are refractory or intolerant to all established MM therapies that are both known to provide clinical benefit and locally available.
* Received at least 3 prior lines of therapy including 1 or more immunomodulatory agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal antibodies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Adequate hematologic, renal and hepatic function as described in the protocol.
* Echocardiogram with ejection fraction \>= 50% and no other clinically significant findings that would increase the participant's susceptibility to cardiac toxicity.
Exclusion Criteria
* Antineoplastic therapy (including any cytotoxic, targeted and/or investigational therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug and through the last dose of study drug.
* Autologous stem cell transplant within 90 days prior to start of study drug.
* Allogenic stem cell transplant within 180 days prior to start of study drug.
* History of acute or chronic pancreatitis.
* Significant unresolved liver disease.
* History of hepatitis B or human immunodeficiency virus (HIV) infection.
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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University of Arizona Cancer Center - North Campus /ID# 219102
Tucson, Arizona, United States
City of Hope /ID# 209786
Duarte, California, United States
Hackensack Univ Med Ctr /ID# 221035
Hackensack, New Jersey, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
Providence, Rhode Island, United States
Prisma Health Cancer Institute-Faris Road /ID# 219076
Greenville, South Carolina, United States
Royal Adelaide Hospital /ID# 223354
Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne /ID# 222066
Fitzroy, Victoria, Australia
Alfred Health /ID# 214665
Melbourne, Victoria, Australia
Perth Blood Institute Ltd /ID# 226650
Nedlands, Western Australia, Australia
Royal Perth Hospital /ID# 225498
Perth, Western Australia, Australia
CHU de Nantes, Hotel Dieu -HME /ID# 215480
Nantes, Pays de la Loire Region, France
Hopital Henri Mondor /ID# 214588
Créteil, , France
Sheba Medical Center /ID# 214065
Ramat Gan, Tel Aviv, Israel
Nagoya City University Hospital /ID# 214696
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 214697
Kashiwa-shi, Chiba, Japan
Kyushu University Hospital /ID# 220800
Fukuoka, Fukuoka, Japan
National Cancer Center Hospital /ID# 214801
Chuo-ku, Tokyo, Japan
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
Pamplona, Navarra, Comunidad, Spain
Hospital Universitario Vall d'Hebron /ID# 214690
Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 214756
Málaga, , Spain
National Taiwan University Hospital /ID# 209322
Taipei City, Taipei, Taiwan
China Medical University Hosp /ID# 209323
Taichung, , Taiwan
Countries
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References
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Yuda J, Will C, Phillips DC, Abraham L, Alvey C, Avigdor A, Buck W, Besenhofer L, Boghaert E, Cheng D, Cojocari D, Doyle K, Hansen TM, Huang K, Johnson EF, Judd AS, Judge RA, Kalvass JC, Kunzer A, Lam LT, Li R, Martin RL, Mastracchio A, Mitten M, Petrich A, Wang J, Ward JE, Zhang H, Wang X, Wolff JE, Bell-McGuinn KM, Souers AJ. Selective MCL-1 inhibitor ABBV-467 is efficacious in tumor models but is associated with cardiac troponin increases in patients. Commun Med (Lond). 2023 Oct 25;3(1):154. doi: 10.1038/s43856-023-00380-z.
Other Identifiers
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2018-003744-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-025
Identifier Type: -
Identifier Source: org_study_id
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