Back to resultsA Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
Primary Purpose
Multiple Myeloma (MM), Cancer
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-467
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma (MM) focused on measuring Multiple Myeloma (MM), Relapse/Refractory, Cancer, ABBV-467
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.
Sites / Locations
- University of Arizona Cancer Center - North Campus /ID# 219102
- City of Hope /ID# 209786
- Hackensack Univ Med Ctr /ID# 221035
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
- Prisma Health Cancer Institute-Faris Road /ID# 219076
- Royal Adelaide Hospital /ID# 223354
- St Vincent's Hospital Melbourne /ID# 222066
- Alfred Health /ID# 214665
- Perth Blood Institute Ltd /ID# 226650
- Royal Perth Hospital /ID# 225498
- CHU de Nantes, Hotel Dieu -HME /ID# 215480
- Hopital Henri Mondor /ID# 214588
- Sheba Medical Center /ID# 214065
- Nagoya City University Hospital /ID# 214696
- National Cancer Center Hospital East /ID# 214697
- Kyushu University Hospital /ID# 220800
- National Cancer Center Hospital /ID# 214801
- CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
- Hospital Universitario Vall d'Hebron /ID# 214690
- CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
- Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
- Hospital Universitario Virgen de la Victoria /ID# 214756
- National Taiwan University Hospital /ID# 209322
- China Medical University Hosp /ID# 209323
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: ABBV-467 Dose Escalation
Part B: ABBV-467 Dose Expansion
Arm Description
ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Change in Vital Signs
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Change in Electrocardiogram (ECG)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Change in Cardiac Enzyme Levels
Change in cardiac enzyme levels will be recorded.
Incidence of Abnormal Clinical Laboratory Test Results
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Maximum Observed Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) of ABBV-467.
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-467
Area Under the Plasma Concentration-Time Curve (AUCt)
AUC from time 0 to time of last measurable concentration of ABBV-467.
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
AUC from time 0 to infinity of ABBV-467.
Clearance of ABBV-467
Clearance of ABBV-467.
Secondary Outcome Measures
Overall Response Rate (ORR)
ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR).
Clinical Benefit Rate (CBR)
CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.
Duration of Response (DOR)
DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04178902
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma (MM), Cancer
Keywords
Multiple Myeloma (MM), Relapse/Refractory, Cancer, ABBV-467
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: ABBV-467 Dose Escalation
Arm Type
Experimental
Arm Description
ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
Arm Title
Part B: ABBV-467 Dose Expansion
Arm Type
Experimental
Arm Description
ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
Intervention Type
Drug
Intervention Name(s)
ABBV-467
Intervention Description
Intravenous (IV) Infusion
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time Frame
Up to approximately 24 months after first dose of study drug
Title
Change in Vital Signs
Description
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Time Frame
Baseline (Week 0) through approximately 24 months after first dose of study drug
Title
Change in Electrocardiogram (ECG)
Description
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time Frame
Baseline (Week 0) through approximately 24 months after first dose of study drug
Title
Change in Cardiac Enzyme Levels
Description
Change in cardiac enzyme levels will be recorded.
Time Frame
Baseline (Week 0) through approximately 24 months after first dose of study drug
Title
Incidence of Abnormal Clinical Laboratory Test Results
Description
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Time Frame
Baseline (Week 0) through approximately 24 months after first dose of study drug
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Maximum Plasma Concentration (Cmax) of ABBV-467.
Time Frame
Up to approximately Day 197
Title
Terminal Phase Elimination Half-life (t1/2)
Description
Terminal phase elimination half-life (t1/2) of ABBV-467
Time Frame
Up to approximately Day 197
Title
Area Under the Plasma Concentration-Time Curve (AUCt)
Description
AUC from time 0 to time of last measurable concentration of ABBV-467.
Time Frame
Up to approximately Day 197
Title
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
Description
AUC from time 0 to infinity of ABBV-467.
Time Frame
Up to approximately Day 197
Title
Clearance of ABBV-467
Description
Clearance of ABBV-467.
Time Frame
Up to approximately Day 197
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR).
Time Frame
Up to approximately 24 months after first dose of study drug
Title
Clinical Benefit Rate (CBR)
Description
CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.
Time Frame
Up to approximately 24 months after first dose of study drug
Title
Duration of Response (DOR)
Description
DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first.
Time Frame
Up to approximately 24 months after first dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - North Campus /ID# 219102
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Facility Name
City of Hope /ID# 209786
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Hackensack Univ Med Ctr /ID# 221035
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4923
Country
United States
Facility Name
Prisma Health Cancer Institute-Faris Road /ID# 219076
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4255
Country
United States
Facility Name
Royal Adelaide Hospital /ID# 223354
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 222066
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Alfred Health /ID# 214665
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Perth Blood Institute Ltd /ID# 226650
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital /ID# 225498
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 215480
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Henri Mondor /ID# 214588
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Sheba Medical Center /ID# 214065
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5239424
Country
Israel
Facility Name
Nagoya City University Hospital /ID# 214696
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Cancer Center Hospital East /ID# 214697
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu University Hospital /ID# 220800
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 214801
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
City
Pamplona
State/Province
Navarra, Comunidad
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 214690
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 214756
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
National Taiwan University Hospital /ID# 209322
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
China Medical University Hosp /ID# 209323
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
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