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

NCT ID: NCT05646836

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2026-11-18

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Dose-Escalation and Expansion: XmAb24306+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.

Group Type: EXPERIMENTAL

Cevostamab

Intervention Type: DRUG

Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

XmAb24306

Intervention Type: DRUG

XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Arm B: Single-Agent Cevostamab Expansion

Participants will receive cevostamab alone.

Group Type: EXPERIMENTAL

Cevostamab

Intervention Type: DRUG

Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Interventions

Cevostamab

Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Intervention Type: DRUG

XmAb24306

XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Intervention Type: DRUG

Tocilizumab

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Intervention Type: DRUG

Other Intervention Names

RO7187797; RO7310729; Actemra, RoActemra

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

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

Petah Tikva, , Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

Oslo University Hospital Rikshospitalet

Oslo, , Norway

Severance Hospital, Yonsei University

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Countries

Australia; Denmark; Greece; Israel; Norway; South Korea; Spain

Other Identifiers

2022-001204-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-505212-38-00

Identifier Type: OTHER

Identifier Source: secondary_id

GO43980

Identifier Type: -

Identifier Source: org_study_id