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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003744-24 | EudraCT Number |
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Strategic considerations
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This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ABBV-467 Dose Escalation | Experimental | ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined. |
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| Part B: ABBV-467 Dose Expansion | Experimental | ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-467 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months after first dose of study drug |
| Change in Vital Signs | Change in vital signs like systolic and diastolic blood pressure will be assessed. | Baseline (Week 0) through approximately 24 months after first dose of study drug |
| Change in Electrocardiogram (ECG) | 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration. | Baseline (Week 0) through approximately 24 months after first dose of study drug |
| Change in Cardiac Enzyme Levels | Change in cardiac enzyme levels will be recorded. | Baseline (Week 0) through approximately 24 months after first dose of study drug |
| Incidence of Abnormal Clinical Laboratory Test Results | Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to approximately 24 months after first dose of study drug |
| Clinical Benefit Rate (CBR) |
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Inclusion Criteria:
Documented diagnosis of multiple myeloma (MM).
Measurable disease defined as at least 1 of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center - North Campus /ID# 219102 | Tucson | Arizona | 85719-1478 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37880389 | Derived | 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. |
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| Baseline (Week 0) through approximately 24 months after first dose of study drug |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Plasma Concentration (Cmax) of ABBV-467. | Up to approximately Day 197 |
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) of ABBV-467 | Up to approximately Day 197 |
| Area Under the Plasma Concentration-Time Curve (AUCt) | AUC from time 0 to time of last measurable concentration of ABBV-467. | Up to approximately Day 197 |
| Area Under the Plasma Concentration-Time Curve (AUC0-infinity) | AUC from time 0 to infinity of ABBV-467. | Up to approximately Day 197 |
| Clearance of ABBV-467 | Clearance of ABBV-467. | Up to approximately Day 197 |
CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR. |
| Up to approximately 24 months after first dose of study drug |
| 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. | Up to approximately 24 months after first dose of study drug |
| City of Hope /ID# 209786 |
| Duarte |
| California |
| 91010 |
| United States |
| Hackensack Univ Med Ctr /ID# 221035 | Hackensack | New Jersey | 07601 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418 | Providence | Rhode Island | 02903-4923 | United States |
| Prisma Health Cancer Institute-Faris Road /ID# 219076 | Greenville | South Carolina | 29605-4255 | United States |
| Royal Adelaide Hospital /ID# 223354 | Adelaide | South Australia | 5000 | Australia |
| St Vincent's Hospital Melbourne /ID# 222066 | Fitzroy | Victoria | 3065 | Australia |
| Alfred Health /ID# 214665 | Melbourne | Victoria | 3004 | Australia |
| Perth Blood Institute Ltd /ID# 226650 | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital /ID# 225498 | Perth | Western Australia | 6000 | Australia |
| CHU de Nantes, Hotel Dieu -HME /ID# 215480 | Nantes | Pays de la Loire Region | 44000 | France |
| Hopital Henri Mondor /ID# 214588 | Créteil | 94000 | France |
| Sheba Medical Center /ID# 214065 | Ramat Gan | Tel Aviv | 5239424 | Israel |
| Nagoya City University Hospital /ID# 214696 | Nagoya | Aichi-ken | 467-8602 | Japan |
| National Cancer Center Hospital East /ID# 214697 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kyushu University Hospital /ID# 220800 | Fukuoka | Fukuoka | 812-8582 | Japan |
| National Cancer Center Hospital /ID# 214801 | Chuo-ku | Tokyo | 104-0045 | Japan |
| CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170 | Pamplona | Navarra, Comunidad | 31008 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 214690 | Barcelona | 08035 | Spain |
| CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739 | Madrid | 28027 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 214672 | Madrid | 28040 | Spain |
| Hospital Universitario Virgen de la Victoria /ID# 214756 | Málaga | 29010 | Spain |
| National Taiwan University Hospital /ID# 209322 | Taipei City | Taipei | 10002 | Taiwan |
| China Medical University Hosp /ID# 209323 | Taichung | 40447 | Taiwan |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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