A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
Genentech, Inc.
Study ID
NCT05646836
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
  • XmAb24306 — DRUG
    XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
  • Tocilizumab — DRUG
    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

Key Dates

Start date
Mar 21, 2023
Status verified
May 2026
Primary completion
Nov 18, 2026
Completion
Nov 18, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab
    Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.
  • Experimental: Arm B: Single-Agent Cevostamab Expansion
    Participants will receive cevostamab alone.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]

Related Studies