Clinical trial NCT05646836: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Serum Concentration of XmAb24306
timeFrame: Up to approximately 3 years
measure: Serum Concentration of Cevostamab
timeFrame: Up to approximately 3 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years
measure: Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
timeFrame: Up to approximately 3 years
measure: Rate of Very Good Partial Response (VGPR)
timeFrame: Up to approximately 3 years
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt - Vejle Sygehus
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athens
country: Greece
facility: University of Athens, Hematological Clinic,
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: