Clinical trial NCT05243342: A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
Official title: A Phase Ib, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 18
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: This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (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:

* Life expectancy of at least 12 weeks
* Measurable disease, as defined by the protocol
* 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
* Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Exclusion Criteria:

* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
* Prior allogeneic stem cell or solid organ transplantation
* Autologous stem cell transplantation within 100 days prior to initiation of study treatment
* Significant cardiovascular disease
* Known clinically significant liver disease
* Active or history of autoimmune disease or immune deficiency
* Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
* Primary or secondary plasma cell leukemia
* Current CNS involvement by MM
* 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: Baseline to approximately 3 years
measure: Objective response rate (ORR)
timeFrame: Baseline to approximately 3 years
measure: Prevalence of XmAb24306 anti-drug antibodies (ADAs)
timeFrame: Baseline to approximately 3 years
measure: Incidence of XmAb24306 ADAs
timeFrame: Baseline to approximately 3 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Odense C
country: Denmark
facility: Odense Universitetshospital
state: South Denmark
city: Vejle
country: Denmark
facility: Sygehus Lillebælt, Vejle
state: South Denmark
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: