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A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab 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: NCT05243342
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (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: XmAb24306 Drug: Daratumumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation
Participants will receive escalating doses of XmAb24306 with daratumumab up to the maximum tolerated dose (MTD)
 Drug: XmAb24306
XmAb24306 will be given via intravenous (IV) infusion
Other Name: RO7310729

Drug: Daratumumab
Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)
Experimental: Dose expansion
Participants will receive XmAb24306 with daratumumab at the recommended phase 2 dose (RP2D)
 Drug: XmAb24306
XmAb24306 will be given via intravenous (IV) infusion
Other Name: RO7310729

Drug: Daratumumab
Participants will receive daratumumab via subcutaneous (SC) injection every week for Cycles 1-4, every 2 weeks for Cycles 5-12, and every 4 weeks thereafter (cycle length = 2 weeks for Cycles 1-12 and 4 weeks thereafter)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with adverse events (AEs) [ Time Frame: Up to approximately 3 years ]

Secondary Outcome Measures :
  1. Serum concentration of XmAb24306 [ Time Frame: Baseline to approximately 3 years ]
  2. Objective response rate (ORR) [ Time Frame: Baseline to approximately 3 years ]
  3. Prevalence of XmAb24306 anti-drug antibodies (ADAs) [ Time Frame: Baseline to approximately 3 years ]
  4. Incidence of XmAb24306 ADAs [ Time Frame: Baseline 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:

  • Life expectancy of at least 12 weeks
  • Measurable disease, as defined by the protocol
  • 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
  • Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Exclusion Criteria:

  • Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
  • Prior allogeneic stem cell or solid organ transplantation
  • Autologous stem cell transplantation within 100 days prior to initiation of study treatment
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  • Active or history of autoimmune disease or immune deficiency
  • Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
  • Primary or secondary plasma cell leukemia
  • Current CNS involvement by MM
  • 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): NCT05243342


Contacts
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Contact: Reference Study ID Number: GO43073 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Norway
Oslo Universitetssykehus HF; Ullevål sykehus Recruiting
Oslo, Norway, 0450
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Complejo Asistencial Universitario de Salamanca ? H. Clinico Recruiting
Salamanca, Spain, 37007
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: NCT05243342    
Other Study ID Numbers: GO43073
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 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
Daratumumab
Antineoplastic Agents