Intravenous ABBV-438 for relapsed/refractory multiple myeloma

A Phase 1, First-in-Human, Open Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ABBV-438 in Adult Subjects With Relapsed or Refractory Multiple Myeloma

This will test IV ABBV-438 in adults with relapsed or refractory multiple myeloma to find a safe dose and see how the drug moves through the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 127 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (industry)
• Locations: 4 sites (Newnan, Georgia and 3 other locations)
• Trial ID: NCT07409246 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label study that gives intravenous ABBV-438 alone to adults with relapsed/refractory multiple myeloma. The study has a dose-escalation phase to identify a recommended dose followed by a dose-expansion phase to confirm that dose. Safety, tolerability, adverse events, and pharmacokinetics (how the drug moves through the body) are the main outcomes. About 127 participants will be enrolled across roughly 24 sites worldwide.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma who have measurable disease and have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent are the intended participants.

Not a fit: Patients with earlier-stage disease, non-measurable myeloma, inadequate organ function, or who do not meet prior therapy exposure requirements are unlikely to benefit from joining this early-phase study.

Why it matters

Potential benefit: If safe and active, ABBV-438 could become a new treatment option for people with relapsed or refractory multiple myeloma.

How similar studies have performed: Other targeted biologics and antibody-based therapies have shown activity in relapsed/refractory multiple myeloma, but ABBV-438 itself is investigational and its safety and effectiveness are unproven in humans.

Eligibility criteria

Inclusion Criteria:

* Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria:

  * Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy;
  * Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.
* Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:

  * Serum M-protein \>= 0.5 g/dL (\>=5 g/L); OR;
  * Urine M-protein \>= 200 mg/24 hours; OR;
  * Involved serum free light chain (sFLC) \>= 10 mg/dL (100mg/L), provided serum FLC ratio is abnormal;
  * Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R/R) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.

Exclusion Criteria:

* Known history of Central Nervous System involvement by MM.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.

Where this trial is running

Newnan, Georgia and 3 other locations

• City Of Hope - Atlanta. /ID# 280294 — Newnan, Georgia, United States (RECRUITING)
• START Midwest /ID# 279035 — Grand Rapids, Michigan, United States (RECRUITING)
• Hadassah Medical Center-Hebrew University /ID# 278865 — Jerusalem, Israel (RECRUITING)
• The Cancer Institute Hospital Of JFCR /ID# 279069 — Koto-ku, Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Multiple Myeloma, ABBV-438, Cancer