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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05646836
Registration number
NCT05646836
Ethics application status
Date submitted
2/12/2022
Date registered
12/12/2022
Date last updated
10/06/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
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Scientific 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
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Secondary ID [1]
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2022-001204-18
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Secondary ID [2]
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GO43980
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cevostamab
Treatment: Drugs - XmAb24306
Treatment: Drugs - Tocilizumab
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.
Experimental: Arm B: Single-Agent Cevostamab Expansion - Participants will receive cevostamab alone.
Treatment: Drugs: Cevostamab
Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Treatment: Drugs: XmAb24306
XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.
Treatment: Drugs: Tocilizumab
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [1]
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Serum Concentration of XmAb24306
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Assessment method [1]
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Serum Concentration of Cevostamab
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Assessment method [2]
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR will be determined by the investigator according to International Myeloma Working Group (IMWG) criteria.
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Rate of Complete Response (CR)/ Stringent Complete Response (sCR)
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Assessment method [4]
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Rate of CR/sCR will be determined by the investigator.
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Rate of Very Good Partial Response (VGPR)
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Assessment method [5]
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Rate of VGPR will be determined by the investigator.
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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Percentage of Participants With Anti-Drug Antibodies (ADA) to XmAb24306 and Cevostamab
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Assessment method [6]
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Timepoint [6]
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Up to approximately 3 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
- Other protocol defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
14/01/2027
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Vejle
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Country [2]
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Greece
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State/province [2]
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Athens
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Country [3]
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Israel
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State/province [3]
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Petach Tikva
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Country [4]
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Israel
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State/province [4]
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Tel Aviv-Yafo
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Country [5]
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Korea, Republic of
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State/province [5]
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Seoul
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Country [6]
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Norway
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State/province [6]
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Oslo
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Country [7]
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Spain
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State/province [7]
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Navarra
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Country [8]
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Spain
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State/province [8]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genentech, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05646836
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: GO43980 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05646836
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