Clinical Trials List
Protocol NumberM19-025
NCT Number(ClinicalTrials.gov Identfier)NCT04178902
2020-09-30 - 2021-05-27
Phase I
Terminated2
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 田豐銘 無
- Jih-Luh Tang 無
- WEI-LI MA 無
- - - 無
- Chien-Chin Lin 無
- 袁章祖 無
- Tai-Chung Huang 無
- HSIN-AN HOU 無
- 劉家豪 無
- CHENG-HONG TSAI 無
- MING YAO 無
- Shang-Yi Huang 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
relapsed/refractory multiple myeloma (MM)/Acute myeloid leukemia(AML)
Objectives
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
Test Drug
ABBV-467
Active Ingredient
ABBV-467
Dosage Form
N/A
Dosage
N/A
Endpoints
Primary Outcome Measures :
Number of Participants with Adverse Events [ Time Frame: Up to approximately 24 months after first dose of study drug ]
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 [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Change in Electrocardiogram (ECG) [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Change in Cardiac Enzyme Levels [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Change in cardiac enzyme levels will be recorded.
Incidence of Abnormal Clinical Laboratory Test Results [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to approximately Day 197 ]
Maximum Plasma Concentration (Cmax) of ABBV-467.
Terminal Phase Elimination Half-life (t1/2) [ Time Frame: Up to approximately Day 197 ]
Terminal phase elimination half-life (t1/2) of ABBV-467
Area Under the Plasma Concentration-Time Curve (AUCt) [ Time Frame: Up to approximately Day 197 ]
AUC from time 0 to time of last measurable concentration of ABBV-467.
Area Under the Plasma Concentration-Time Curve (AUC0-infinity) [ Time Frame: Up to approximately Day 197 ]
AUC from time 0 to infinity of ABBV-467.
Clearance of ABBV-467 [ Time Frame: Up to approximately Day 197 ]
Clearance of ABBV-467.
Number of Participants with Adverse Events [ Time Frame: Up to approximately 24 months after first dose of study drug ]
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 [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Change in Electrocardiogram (ECG) [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Change in Cardiac Enzyme Levels [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Change in cardiac enzyme levels will be recorded.
Incidence of Abnormal Clinical Laboratory Test Results [ Time Frame: Baseline (Week 0) through approximately 24 months after first dose of study drug ]
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to approximately Day 197 ]
Maximum Plasma Concentration (Cmax) of ABBV-467.
Terminal Phase Elimination Half-life (t1/2) [ Time Frame: Up to approximately Day 197 ]
Terminal phase elimination half-life (t1/2) of ABBV-467
Area Under the Plasma Concentration-Time Curve (AUCt) [ Time Frame: Up to approximately Day 197 ]
AUC from time 0 to time of last measurable concentration of ABBV-467.
Area Under the Plasma Concentration-Time Curve (AUC0-infinity) [ Time Frame: Up to approximately Day 197 ]
AUC from time 0 to infinity of ABBV-467.
Clearance of ABBV-467 [ Time Frame: Up to approximately Day 197 ]
Clearance of ABBV-467.
Inclution 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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
108 participants
