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Активно (без набиране) Фаза 1 NCT05646836

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Multiple Myeloma

Спонсор: Genentech, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 7
Австралия (1)
Royal Adelaide Hospital
Adelaide , South Australia
Дания (1)
Sygehus Lillebaelt - Vejle Sygehus
Vejle
Гърция (1)
Evangelismos General Hospital of Athens
Athens
Израел (1)
Rabin Medical Center-Beilinson Campus
Petah Tikva
Норвегия (1)
Oslo University Hospital Rikshospitalet
Oslo
Южна Корея (1)
Severance Hospital, Yonsei University
Seoul
Испания (1)
Clinica Universidad de Navarra
Pamplona , Navarre
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.03.2023
Крайна дата
18.11.2026
Регистрационен номер
NCT05646836
Източник
anzctr
Запитване за медицински туризъм

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