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A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma

Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT04178902
Collaborator
(none)
8
Enrollment
24
Locations
2
Arms
10.9
Actual Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Actual Study Start Date :
May 19, 2020
Actual Primary Completion Date :
Apr 16, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: ABBV-467 Dose Escalation

ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.

Drug: ABBV-467
Intravenous (IV) Infusion
Experimental: Part B: ABBV-467 Dose Expansion

ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.

Drug: ABBV-467
Intravenous (IV) Infusion

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Events [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.

  2. Change in Vital Signs [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.

  3. Change in Electrocardiogram (ECG) [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.

  4. Change in Cardiac Enzyme Levels [Baseline (Week 0) through approximately 24 months after first dose of study drug]

    Change in cardiac enzyme levels will be recorded.

  5. Incidence of Abnormal Clinical Laboratory Test Results [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.

  6. Maximum Observed Plasma Concentration (Cmax) [Up to approximately Day 197]

    Maximum Plasma Concentration (Cmax) of ABBV-467.

  7. Terminal Phase Elimination Half-life (t1/2) [Up to approximately Day 197]

    Terminal phase elimination half-life (t1/2) of ABBV-467

  8. Area Under the Plasma Concentration-Time Curve (AUCt) [Up to approximately Day 197]

    AUC from time 0 to time of last measurable concentration of ABBV-467.

  9. Area Under the Plasma Concentration-Time Curve (AUC0-infinity) [Up to approximately Day 197]

    AUC from time 0 to infinity of ABBV-467.

  10. Clearance of ABBV-467 [Up to approximately Day 197]

    Clearance of ABBV-467.

Secondary Outcome Measures

  1. Overall Response Rate (ORR) [Up to approximately 24 months after first dose of study drug]

    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).

  2. Clinical Benefit Rate (CBR) [Up to approximately 24 months after first dose of study drug]

    CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.

  3. Duration of Response (DOR) [Up to approximately 24 months after first dose of study drug]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arizona Cancer Center - North Campus /ID# 219102 Tucson Arizona United States 85719-1478
2 City of Hope /ID# 209786 Duarte California United States 91010
3 Hackensack Univ Med Ctr /ID# 221035 Hackensack New Jersey United States 07601
4 Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418 Providence Rhode Island United States 02903-4923
5 Prisma Health Cancer Institute-Faris Road /ID# 219076 Greenville South Carolina United States 29605-4255
6 Royal Adelaide Hospital /ID# 223354 Adelaide South Australia Australia 5000
7 St Vincent's Hospital Melbourne /ID# 222066 Fitzroy Victoria Australia 3065
8 Alfred Health /ID# 214665 Melbourne Victoria Australia 3004
9 Perth Blood Institute Ltd /ID# 226650 Nedlands Western Australia Australia 6009
10 Royal Perth Hospital /ID# 225498 Perth Western Australia Australia 6000
11 CHU de Nantes, Hotel Dieu -HME /ID# 215480 Nantes Pays-de-la-Loire France 44000
12 Hopital Henri Mondor /ID# 214588 Creteil France 94000
13 Sheba Medical Center /ID# 214065 Ramat Gan Tel-Aviv Israel 5239424
14 Nagoya City University Hospital /ID# 214696 Nagoya shi Aichi Japan 467-8602
15 National Cancer Center Hospital East /ID# 214697 Kashiwa-shi Chiba Japan 277-8577
16 Kyushu University Hospital /ID# 220800 Fukuoka-shi Fukuoka Japan 812-8582
17 National Cancer Center Hospital /ID# 214801 Chuo-ku Tokyo Japan 104-0045
18 CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170 Pamplona Navarra, Comunidad Spain 31008
19 Hospital Universitario Vall d'Hebron /ID# 214690 Barcelona Spain 08035
20 CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739 Madrid Spain 28027
21 Hospital Universitario Fundacion Jimenez Diaz /ID# 214672 Madrid Spain 28040
22 Hospital Universitario Virgen de la Victoria /ID# 214756 Malaga Spain 29010
23 National Taiwan University Hospital /ID# 209322 Taipei City Taipei Taiwan 10002
24 China Medical University Hosp /ID# 209323 Taichung City Taiwan 40447

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT04178902
Other Study ID Numbers:
  • M19-025
  • 2018-003744-24
First Posted:
Nov 26, 2019
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by AbbVie
Multiple Myeloma (MM)
Relapse/Refractory
Cancer
ABBV-467
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 26, 2021