Clinical trial · Interventional
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
NCT04178902CI-TRIAL-00052894terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-467 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: ABBV-467 Dose Escalation
- description
- ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
- interventionNames
- Drug: ABBV-467
- type
- EXPERIMENTAL
- label
- Part B: ABBV-467 Dose Expansion
- description
- ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
- interventionNames
- Drug: ABBV-467
Primary outcomes (10)
- measure
- Number of Participants with Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYuda 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. PMID 37880389