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NCT04434469 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2024-07-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Time to Maximum Concentration Observed (Tmax) of RO7297089

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outcome · POSTED

Area Under the Curve (AUC) of RO7297089

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outcome · POSTED

Maximum Concentration Observed (Cmax) of RO7297089

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outcome · POSTED

Minimum Concentration Observed (Cmin) of RO7297089

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outcome · POSTED

Half-life (t1/2) of RO7297089

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outcome · POSTED

Objective Response Rate (ORR)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    intervention Names
    1. Drug: RO7297089
    label
    Arm A Flat Dose Escalation: RO7297089
    type
    EXPERIMENTAL
  2. description
    Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
    intervention Names
    1. Drug: RO7297089
    label
    Arm B Split Dose Escalation: RO7297089
    type
    EXPERIMENTAL
  3. description
    No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
    intervention Names
    1. Drug: RO7297089
    label
    Arm C Step Dose Escalation: RO7297089
    type
    EXPERIMENTAL
  4. description
    No participants enrolled. Enrollment for the GO41582 study was stopped in July 2021 due to limited activity as a single agent which did not meet the Sponsor's internal criteria for further clinical development.
    intervention Names
    1. Drug: RO7297089
    label
    Phase I Expansion Stage: RO7297089
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A Flat Dose Escalation: RO7297089
    2. Arm B Split Dose Escalation: RO7297089
    3. Arm C Step Dose Escalation: RO7297089
    4. Phase I Expansion Stage: RO7297089
    description
    RO7297089 will be given via intravenous (IV) infusion
    name
    RO7297089
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
27
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Adverse event severity graded according to NCI CTCAE v5.0
    measure
    Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
    time Frame
    Baseline up to 1 year 7 months
secondary Outcomes
  1. measure
    Time to Maximum Concentration Observed (Tmax) of RO7297089
    time Frame
    Cycle 1 Day 1
  2. measure
    Area Under the Curve (AUC) of RO7297089
    time Frame
    Cycle 1 Day 1
  3. measure
    Maximum Concentration Observed (Cmax) of RO7297089
    time Frame
    Cycle 1 Day 1, Cycle 2 Day 8
  4. measure
    Minimum Concentration Observed (Cmin) of RO7297089
    time Frame
    Cycle 1 Day 1, Cycle 2 Day 8
  5. measure
    Half-life (t1/2) of RO7297089
    time Frame
    Cycle 1 Day 1
  6. description
    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
    measure
    Objective Response Rate (ORR)
    time Frame
    Baseline up to approximately 19 months
Full study description
brief 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.
Source references
references
  1. citation
    Plesner T, Harrison SJ, Quach H, Lee C, Bryant A, Vangsted A, Estell J, Delforge M, Offner F, Twomey P, Choeurng V, Li J, Hendricks R, Ruppert SM, Sumiyoshi T, Miller K, Cho E, Schjesvold F. Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma. Clin Hematol Int. 2023 Mar;5(1):43-51. doi: 10.1007/s44228-022-00023-5. Epub 2023 Jan 19.
    pmid
    36656461
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice