A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05646836
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab XmAb24306 Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab Tocilizumab Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab Cevostamab Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled. Arm B: Single-Agent Cevostamab Expansion Tocilizumab Participants will receive cevostamab alone. Arm B: Single-Agent Cevostamab Expansion Cevostamab Participants will receive cevostamab alone.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) Up to approximately 3 years 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.
- Secondary Outcome Measures
Name Time Method Rate of Complete Response (CR)/ Stringent Complete Response (sCR) Up to approximately 3 years Rate of CR/sCR will be determined by the investigator.
Serum Concentration of XmAb24306 Up to approximately 3 years Serum Concentration of Cevostamab Up to approximately 3 years Objective Response Rate (ORR) Up to approximately 3 years ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.
Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab Up to approximately 3 years Rate of Very Good Partial Response (VGPR) Up to approximately 3 years Rate of VGPR will be determined by the investigator.
Trial Locations
- Locations (13)
Peter Maccallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Sygehus Lillebaelt - Vejle Sygehus
🇩🇰Vejle, Denmark
Evangelismos General Hospital of Athens
🇬🇷Athens, Greece
University of Athens, Hematological Clinic,
🇬🇷Athens, Greece
Rabin Medical Center-Beilinson Campus
🇮🇱Petach Tikva, Israel
Tel Aviv Sourasky Medical Center PPDS
🇮🇱Tel Aviv-Yafo, Israel
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Oslo University Hospital Rikshospitalet
🇳🇴Oslo, Norway
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of