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CompletedLast updated: 9 January 2024

This phase I trial is trying to understand how a new intravenous drug works, and if it is safe and tolerable to use, in the treatment of patients with multiple myelomaAn Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

Clinical summary

Summary

This is a dose escalation study of intravenous drug, RO7297089. Cohorts of at least three patients will be treated in the dose escalation phase and receive escalating doses of RO7297089 to determine a maximum tolerated/administered dose (MTD). Once the dose escalation phase is complete, approximately 30 eligible patients will be enrolled in the dose expansion phase and receive the recommended phase 2 dose (at or below the MTD, determined in the dose escalation phase).

Conditions

This trial is treating patients with multiple myeloma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Genentech

Scientific Title

An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

Eligibility

Inclusion

  • 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

  • Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer 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 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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