A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243342
• Other study ID #: GO43073
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO43073 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• XmAb24306
XmAb24306 will be given via intravenous (IV) infusion
• Daratumumab
Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Alfred Hospital	Melbourne	Victoria
Australia	The Perth Blood Institute	Nedlands	Western Australia
Denmark	Odense Universitetshospital	Odense C
Denmark	Sygehus Lillebælt, Vejle	Vejle
Norway	Oslo Universitetssykehus HF; Ullevål sykehus	Oslo
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Complejo Asistencial Universitario de Salamanca ? H. Clinico	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Australia,  Denmark,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with adverse events (AEs)		Up to approximately 3 years
Secondary	Serum concentration of XmAb24306		Baseline to approximately 3 years
Secondary	Objective response rate (ORR)		Baseline to approximately 3 years
Secondary	Prevalence of XmAb24306 anti-drug antibodies (ADAs)		Baseline to approximately 3 years
Secondary	Incidence of XmAb24306 ADAs		Baseline to approximately 3 years