Multiple Myeloma (MM)Phase 1NCT04178902
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
A Phase 1 study testing ABBV-467 in people with Multiple Myeloma (MM) and Cancer, run by AbbVie at 24 sites in 7 countries.
Trial summary
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Cancer
- What is being tested?
- ABBV-467
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 19 May 2020to 16 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States5 sites
City of Hope /ID# 209786
Duarte, California, 91010
Prisma Health Cancer Institute-Faris Road /ID# 219076
Greenville, South Carolina, 29605-4255
Hackensack Univ Med Ctr /ID# 221035
Hackensack, New Jersey, 07601
Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418
Providence, Rhode Island, 02903-4923
University of Arizona Cancer Center - North Campus /ID# 219102
Tucson, Arizona, 85719-1478
Australia5 sites
Royal Adelaide Hospital /ID# 223354
Adelaide, South Australia, 5000
St Vincent's Hospital Melbourne /ID# 222066
Fitzroy, Victoria, 3065
Alfred Health /ID# 214665
Melbourne, Victoria, 3004
Perth Blood Institute Ltd /ID# 226650
Nedlands, Western Australia, 6009
Royal Perth Hospital /ID# 225498
Perth, Western Australia, 6000
Spain5 sites
Hospital Universitario Vall d'Hebron /ID# 214690
Barcelona, 08035
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739
Madrid, 28027
Hospital Universitario Fundacion Jimenez Diaz /ID# 214672
Madrid, 28040
Hospital Universitario Virgen de la Victoria /ID# 214756
Málaga, 29010
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170
Pamplona, Navarra, Comunidad, 31008
Japan4 sites
National Cancer Center Hospital /ID# 214801
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital /ID# 220800
Fukuoka, Fukuoka, 812-8582
National Cancer Center Hospital East /ID# 214697
Kashiwa-shi, Chiba, 277-8577
Nagoya City University Hospital /ID# 214696
Nagoya, Aichi-ken, 467-8602
France2 sites
Hopital Henri Mondor /ID# 214588
Créteil, 94000
CHU de Nantes, Hotel Dieu -HME /ID# 215480
Nantes, Pays de la Loire Region, 44000
Taiwan2 sites
China Medical University Hosp /ID# 209323
Taichung, 40447
National Taiwan University Hospital /ID# 209322
Taipei City, Taipei, 10002
About this study
Official title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
- Conditions
- Multiple Myeloma (MM), Cancer
- Being tested
- ABBV-467
- Keywords
- Multiple Myeloma (MM), Relapse/Refractory, Cancer, ABBV-467
- Medical subject headings
- Multiple Myeloma, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-467Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ABBV-467 |
| Part B: ABBV-467 Dose Expansion | Experimental | ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A. Receives: Drug: ABBV-467 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately Day 197
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2) of ABBV-467
Measured: 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.
Measured: Up to approximately Day 197
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
AUC from time 0 to infinity of ABBV-467.
Measured: Up to approximately Day 197
Clearance of ABBV-467
Clearance of ABBV-467.
Measured: Up to approximately Day 197
Secondary outcomes (3)
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).
Measured: Up to approximately 24 months after first dose of study drug
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.
Measured: 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.
Measured: Up to approximately 24 months after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start19 May 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178902
- Sponsor's protocol ID
- M19-025
- Other IDs
- 2018-003744-24, 2018
- Status last verified
- Jul 2021
- First submitted
- 25 Nov 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37880389
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First In Human Study of the MCL-1 Inhibitor, ABBV-467
- ClinicalTrials.gov ID
- NCT04178902
- Acronym / sponsor ID
- M19-025
- Conditions
- Multiple Myeloma (MM), Cancer
- Keywords
- Multiple Myeloma (MM), Relapse/Refractory, Cancer, ABBV-467
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 May 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: ABBV-467 Dose Escalation | Experimental | Drug: ABBV-467ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined. |
| Part B: ABBV-467 Dose Expansion | Experimental | Drug: ABBV-467ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-467Intravenous (IV) Infusion | Drug | Part A: ABBV-467 Dose Escalation, Part B: ABBV-467 Dose Expansion |
Primary outcome
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.
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months after first dose of study drug
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 24 months after first dose of study drug
Duration of Response (DOR)
Time frame: Up to approximately 24 months after first dose of study drug
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Derived from this study: PubMed 37880389Yuda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-467 in people with Multiple Myeloma (MM) and Cancer, run by AbbVie at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Spain, Japan, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to approximately 24 months after first dose of study drug). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.