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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04178902




Registration number
NCT04178902
Ethics application status
Date submitted
25/11/2019
Date registered
26/11/2019
Date last updated
16/04/2020

Titles & IDs
Public title
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Secondary ID [1] 0 0
2018-003744-24
Secondary ID [2] 0 0
M19-025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM) 0 0
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-467

Experimental: Part A: ABBV-467 Dose Escalation - ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended Part B dose is determined.

Experimental: Part B: ABBV-467 Dose Expansion - ABBV-467 administered by intravenous (IV) infusion at multiple dose levels and/or schedules as identified in Part A.


Treatment: Drugs: ABBV-467
Intravenous (IV) Infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 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.
Timepoint [1] 0 0
Up to approximately 24 months after first dose of study drug
Primary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax) - Maximum Serum Concentration (Cmax) of ABBV-467.
Timepoint [2] 0 0
Up to approximately Day 197
Primary outcome [3] 0 0
Terminal Phase Elimination Half-life (t1/2) - Terminal phase elimination half-life (t1/2) of ABBV-467
Timepoint [3] 0 0
Up to approximately Day 197
Primary outcome [4] 0 0
Area Under the Plasma Concentration-Time Curve (AUCt) - AUC from time 0 to time of last measureable concentration of ABBV-467.
Timepoint [4] 0 0
Up to approximately Day 197
Primary outcome [5] 0 0
Area Under the Plasma Concentration-Time Curve (AUC0-8) - AUC from time 0 to infinity.
Timepoint [5] 0 0
Up to approximately Day 197
Primary outcome [6] 0 0
Clearance of ABBV-467 - Clearance of ABBV-467.
Timepoint [6] 0 0
Up to approximately Day 197
Secondary outcome [1] 0 0
Overall Response Rate (ORR) - 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).
Timepoint [1] 0 0
Up to approximately 24 months after first dose of study drug
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to approximately 24 months after first dose of study drug
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to approximately 24 months after first dose of study drug

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital /ID# 214665 - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Rhode Island
Country [3] 0 0
France
State/province [3] 0 0
Creteil
Country [4] 0 0
France
State/province [4] 0 0
Nantes
Country [5] 0 0
Israel
State/province [5] 0 0
Ramat Gan
Country [6] 0 0
Japan
State/province [6] 0 0
Aichi
Country [7] 0 0
Japan
State/province [7] 0 0
Chiba
Country [8] 0 0
Japan
State/province [8] 0 0
Tokyo
Country [9] 0 0
Spain
State/province [9] 0 0
Navarra, Comunidad
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Malaga
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taichung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04178902
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04178902