Clinical Trials /

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

NCT04178902

Description:

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

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory Multiple Myeloma
  • Official Title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467

Clinical Trial IDs

  • ORG STUDY ID: M19-025
  • SECONDARY ID: 2018-003744-24
  • NCT ID: NCT04178902

Conditions

  • Multiple Myeloma (MM)
  • Cancer

Interventions

DrugSynonymsArms
ABBV-467Part A: ABBV-467 Dose Escalation

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Part A: ABBV-467 Dose EscalationExperimentalABBV-467 administered by intravenous (IV) infusion at various doses until a recommended Part B dose is determined.
  • ABBV-467
Part B: ABBV-467 Dose ExpansionExperimentalABBV-467 administered by intravenous (IV) infusion at multiple dose levels and/or schedules as identified in Part A.
  • 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 or urine M-protein ≥ 200mg/24 hours

          -  Relapsed after or are refractory or intolerant to all established MM therapies that
             are 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

          -  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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events
Time Frame:Up to approximately 24 months after first dose of study drug
Safety Issue:
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 assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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.

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 24 months after first dose of study drug
Safety Issue:
Description:ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial remission (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR).
Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to approximately 24 months after first dose of study drug
Safety Issue:
Description:CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 24 months after first dose of study drug
Safety Issue:
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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Multiple Myeloma (MM)
  • Relapse/Refractory
  • Cancer

Last Updated

November 25, 2019