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

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma (MM); Cancer

Treatments: Drug: ABBV-467

Study type: Interventional

Funder types: Industry

Identifiers

NCT04178902

M19-025

2018-003744-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Part A: ABBV-467 Dose Escalation

Experimental group

Description:

ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.

Treatment:

Drug: ABBV-467

Part B: ABBV-467 Dose Expansion

Experimental group

Description:

ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.

Treatment:

Drug: ABBV-467