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Active (not recruiting) Phase 1 NCT05646836

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

Phase 1 – testing safety in a small group of people
Conditions: Multiple Myeloma

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 7
Australia (1)
Royal Adelaide Hospital
Adelaide , South Australia
Denmark (1)
Sygehus Lillebaelt - Vejle Sygehus
Vejle
Greece (1)
Evangelismos General Hospital of Athens
Athens
Israel (1)
Rabin Medical Center-Beilinson Campus
Petah Tikva
Norway (1)
Oslo University Hospital Rikshospitalet
Oslo
South Korea (1)
Severance Hospital, Yonsei University
Seoul
Spain (1)
Clinica Universidad de Navarra
Pamplona , Navarre
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.03.2023
Completion date
18.11.2026
Registry ID
NCT05646836
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.