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Completed

NCT Number: NCT05243342

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Life expectancy of at least 12 weeks
  • Measurable disease, as defined by the protocol
  • Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
  • Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Exclusion criteria

  • Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
  • Prior allogeneic stem cell or solid organ transplantation
  • Autologous stem cell transplantation within 100 days prior to initiation of study treatment
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  • Active or history of autoimmune disease or immune deficiency
  • Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
  • Primary or secondary plasma cell leukemia
  • Current CNS involvement by MM
  • Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

XmAb24306

Drug

XmAb24306 will be given via intravenous (IV) infusion

Other names: RO7310729

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)

Primary outcomes

  1. Percentage of participants with adverse events (AEs)

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Serum concentration of XmAb24306

    Time frame: Baseline to approximately 3 years

  2. Objective response rate (ORR)

    Time frame: Baseline to approximately 3 years

  3. Prevalence of XmAb24306 anti-drug antibodies (ADAs)

    Time frame: Baseline to approximately 3 years

  4. Incidence of XmAb24306 ADAs

    Time frame: Baseline to approximately 3 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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