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Completed

NCT Number: NCT04434469

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

RO7297089

Drug

RO7297089 will be given via intravenous (IV) infusion

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)

    Time frame: Baseline up to 1 year 7 months

    Adverse event severity graded according to NCI CTCAE v5.0

Secondary outcomes

  1. Time to Maximum Concentration Observed (Tmax) of RO7297089

    Time frame: Cycle 1 Day 1

  2. Area Under the Curve (AUC) of RO7297089

    Time frame: Cycle 1 Day 1

  3. Maximum Concentration Observed (Cmax) of RO7297089

    Time frame: Cycle 1 Day 1, Cycle 2 Day 8

  4. Minimum Concentration Observed (Cmin) of RO7297089

    Time frame: Cycle 1 Day 1, Cycle 2 Day 8

  5. Half-life (t1/2) of RO7297089

    Time frame: Cycle 1 Day 1

  6. Objective Response Rate (ORR)

    Time frame: Baseline up to approximately 19 months

    ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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