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NCT Number: NCT05646836

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • 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.
  • Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.
  • Measurable disease, as defined by the protocol
  • Participants agree to follow contraception or abstinence requirements as defined in the protocol

Exclusion criteria

  • Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol
  • Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment
  • Participants with prior allogeneic SCT or solid organ transplantation
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Active or history of autoimmune disease
  • Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM)
  • Significant cardiovascular disease
  • Participants with known clinically significant liver disease
  • Symptomatic active pulmonary disease requiring supplemental oxygen
  • Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration
  • Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
  • Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

Cevostamab

Drug

Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Other names: RO7187797

XmAb24306

Drug

XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Other names: RO7310729

Tocilizumab

Drug

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Other names: Actemra, RoActemra

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 3 years

    Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Secondary outcomes

  1. Serum Concentration of XmAb24306

    Time frame: Up to approximately 3 years

  2. Serum Concentration of Cevostamab

    Time frame: Up to approximately 3 years

  3. Objective Response Rate (ORR)

    Time frame: Up to approximately 3 years

    ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.

  4. Rate of Complete Response (CR)/ Stringent Complete Response (sCR)

    Time frame: Up to approximately 3 years

    Rate of CR/sCR will be determined by the investigator.

  5. Rate of Very Good Partial Response (VGPR)

    Time frame: Up to approximately 3 years

    Rate of VGPR will be determined by the investigator.

  6. Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab

    Time frame: Up 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, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Patients With Relapsed/Refractory Multiple Myeloma

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2022
Registry last updated
May 14, 2026

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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