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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646836
• Other study ID #: GO43980
• Secondary ID: 2022-001204-1820
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2023
• Est. completion date: January 14, 2027

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO43980 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 14, 2027
• Est. primary completion date: August 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
• XmAb24306
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
• Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Denmark	Sygehus Lillebaelt - Vejle Sygehus	Vejle
Greece	Evangelismos General Hospital of Athens	Athens
Greece	University of Athens Medical School - Regional General Hospital Alexandra	Athens
Israel	Rabin Medical Center-Beilinson Campus	Petach Tikva
Israel	Tel Aviv Sourasky Medical Center PPDS	Tel Aviv-Yafo
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Norway	Oslo University Hospital Rikshospitalet	Oslo
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Australia,  Denmark,  Greece,  Israel,  Korea, Republic of,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs)	Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine Release Syndrome (CRS), will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.	Up to approximately 3 years
Secondary	Serum Concentration of XmAb24306		Up to approximately 3 years
Secondary	Serum Concentration of Cevostamab		Up to approximately 3 years
Secondary	Objective Response Rate (ORR)	ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.	Up to approximately 3 years
Secondary	Rate of Complete Response (CR)/ Stringent Complete Response (sCR)	Rate of CR/sCR will be determined by the investigator.	Up to approximately 3 years
Secondary	Rate of Very Good Partial Response (VGPR)	Rate of VGPR will be determined by the investigator.	Up to approximately 3 years
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab		Up to approximately 3 years