A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
Genentech, Inc.
Study ID
NCT05243342
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • XmAb24306 — DRUG
    XmAb24306 will be given via intravenous (IV) infusion
  • Daratumumab — DRUG
    Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)

Study Details

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (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
Apr 28, 2022
Status verified
Feb 2025
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
  • Experimental: Dose expansion
    Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)

Primary Outcome Measure

Percentage of participants with adverse events (AEs) [ Time Frame: Up to approximately 3 years ]

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