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Clinical Trials in Denmark / NCT05646836
Active, not recruiting Phase 1

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

NCT05646836 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 1
Started
2023-03-21
Last updated
2026-08-11

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Cevostamab →XmAb24306Tocilizumab →

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

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Royal Adelaide Hospital Adelaide South Australia
Peter Maccallum Cancer Centre Melbourne Victoria
Alfred Hospital Melbourne Victoria
Sygehus Lillebaelt - Vejle Sygehus Vejle Denmark
Evangelismos General Hospital of Athens Athens Greece
University of Athens, Hematological Clinic, Athens Greece
Rabin Medical Center-Beilinson Campus Petah Tikva Israel
Tel Aviv Sourasky Medical Center PPDS Tel Aviv Israel
Oslo University Hospital Rikshospitalet Oslo Norway
Severance Hospital, Yonsei University Seoul South Korea
Asan Medical Center - PPDS Seoul South Korea
Clinica Universidad de Navarra Pamplona Navarre
Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain

On this site

📄 Actemra (tocilizumab) drug profile →

More Genentech, Inc. trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05646836 on ClinicalTrials.gov ↗ ← All trials in Denmark