Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05646836
Other study ID # GO43980
Secondary ID 2022-001204-1820
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1