A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Genentech, Inc.
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Updated on 5 August 2020
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measurable disease
multiple myeloma
refractory multiple myeloma

Summary

This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.

Details
Condition Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Age 18years - 100years
Treatment RO7297089
Clinical Study IdentifierNCT04434469
SponsorGenentech, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
Measurable disease

Exclusion Criteria

Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before first RO7297089 infusion
Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
Prior treatment with CAR-T therapy within 90 days before first study drug administration
Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
Primary or secondary plasma cell leukemia
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
Significant cardiovascular disease
Current CNS involvement by MM
Clear my responses
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