Description:
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult
participants with relapsed/refractory multiple myeloma (MM).
Title
- Brief Title: A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) 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
| Drug | Synonyms | Arms |
|---|
| ABBV-467 | | Part 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
| Name | Type | Description | Interventions |
|---|
| 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. | |
| Part B: ABBV-467 Dose Expansion | Experimental | ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A. | |
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.
- 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.
| 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 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. |
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 response (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: | Terminated |
| Lead Sponsor: | AbbVie |
Trial Keywords
- Multiple Myeloma (MM)
- Relapse/Refractory
- Cancer
- ABBV-467
Last Updated
July 26, 2021
