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

NCT05646836 | Active Not Recruiting Phase 1

• 3 other identifiers: GO439802022-001204-182023-505212-38-00
• Study Type: interventional
• Target: 90
• Locations: 7 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Rate of Complete Response (CR)/ Stringent Complete Response (sCR)

  Up to approximately 3 years

• Rate of Very Good Partial Response (VGPR)

  Up to approximately 3 years

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Cevostamab; Drug: XmAb24306; Drug: Tocilizumab

Arm B: Single-Agent Cevostamab Expansion

EXPERIMENTAL

Participants will receive cevostamab alone.

Drug: Cevostamab; Drug: Tocilizumab

Interventions

Cevostamab DRUG

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

Also known as: RO7187797

Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab; Arm B: Single-Agent Cevostamab Expansion

XmAb24306 DRUG

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

Also known as: RO7310729

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

Tocilizumab DRUG

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

Also known as: Actemra, RoActemra

Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab; Arm B: Single-Agent Cevostamab Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (13)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sygehus Lillebaelt - Vejle Sygehus

Vejle, 7100, Denmark

Location

Evangelismos General Hospital of Athens

Athens, 106 76, Greece

Location

University of Athens, Hematological Clinic,

Athens, 115 28, Greece

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 64239, Israel

Location

Oslo University Hospital Rikshospitalet

Oslo, N - 0424, Norway

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Asan Medical Center - PPDS

Seoul, 05505, South Korea

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: March 21, 2023
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); AU (3); IL (2); DK (1); GR (2); NO (1); KR (2)