Clinical trial NCT04178902: A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
Official title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma (MM)
Cancer
Keywords: Multiple Myeloma (MM)
Relapse/Refractory
Cancer
ABBV-467
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of multiple myeloma (MM).
* 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:

* Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.
* 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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to approximately 24 months after first dose of study drug
measure: Change in Vital Signs
timeFrame: Baseline (Week 0) through approximately 24 months after first dose of study drug
measure: Change in Electrocardiogram (ECG)
timeFrame: Baseline (Week 0) through approximately 24 months after first dose of study drug
measure: Change in Cardiac Enzyme Levels
timeFrame: Baseline (Week 0) through approximately 24 months after first dose of study drug
measure: Incidence of Abnormal Clinical Laboratory Test Results
timeFrame: Baseline (Week 0) through approximately 24 months after first dose of study drug
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to approximately Day 197
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: Up to approximately Day 197
measure: Area Under the Plasma Concentration-Time Curve (AUCt)
timeFrame: Up to approximately Day 197
measure: Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
timeFrame: Up to approximately Day 197
measure: Clearance of ABBV-467
timeFrame: Up to approximately Day 197
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 24 months after first dose of study drug
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 24 months after first dose of study drug
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months after first dose of study drug
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 219102
state: Arizona
city: Duarte
country: United States
facility: City of Hope /ID# 209786
state: California
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 221035
state: New Jersey
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health Cancer Institute-Faris Road /ID# 219076
state: South Carolina
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 223354
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 222066
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health /ID# 214665
state: Victoria
city: Nedlands
country: Australia
facility: Perth Blood Institute Ltd /ID# 226650
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 225498
state: Western Australia
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 215480
state: Pays-de-la-Loire
city: Creteil
country: France
facility: Hopital Henri Mondor /ID# 214588
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 214065
state: Tel-Aviv
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 214696
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 214697
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 220800
state: Fukuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 214801
state: Tokyo
city: Pamplona
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
state: Navarra, Comunidad
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 214690
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 214756
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 209322
state: Taipei
city: Taichung City
country: Taiwan
facility: China Medical University Hosp /ID# 209323
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: