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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05646836
Recruitment Status : Recruiting
First Posted : December 12, 2022
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cevostamab Drug: XmAb24306 Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 15, 2023
Estimated Primary Completion Date : August 21, 2026
Estimated Study Completion Date : January 14, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Other Name: RO7187797

Drug: XmAb24306
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Other Name: RO7310729

Drug: Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Other Name: Actemra, RoActemra
Experimental: Arm B: Single-Agent Cevostamab Expansion
Participants will receive cevostamab alone.
 Drug: Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Other Name: RO7187797

Drug: Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
Other Name: Actemra, RoActemra


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: 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 :
  1. Serum Concentration of XmAb24306 [ Time Frame: Up to approximately 3 years ]
  2. Serum Concentration of Cevostamab [ Time Frame: Up to approximately 3 years ]
  3. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.

  4. Rate of Complete Response (CR)/ Stringent Complete Response (sCR) [ Time Frame: Up to approximately 3 years ]
    Rate of CR/sCR will be determined by the investigator.

  5. Rate of Very Good Partial Response (VGPR) [ Time Frame: Up to approximately 3 years ]
    Rate of VGPR will be determined by the investigator.

  6. Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab [ Time Frame: Up to approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05646836


Contacts
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Contact: Reference Study ID Number: GO43980 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Australia, Victoria
Peter Maccallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Greece
Evangelismos General Hospital of Athens Recruiting
Athens, Greece, 106 76
University of Athens Medical School - Regional General Hospital Alexandra Recruiting
Athens, Greece, 115 28
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05646836    
Other Study ID Numbers: GO43980
2022-001204-18 ( EudraCT Number )
First Posted: December 12, 2022    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases