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

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ClinicalTrials.gov Identifier: NCT04434469
Recruitment Status : Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Relapsed Multiple Myeloma Drug: RO7297089 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Arm A Flat Dose Escalation: RO7297089
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Drug: RO7297089
RO7297089 will be given via intravenous (IV) infusion

Experimental: Arm B Split Dose Escalation: RO7297089
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.
Drug: RO7297089
RO7297089 will be given via intravenous (IV) infusion

Experimental: Arm C Step Dose Escalation: RO7297089
Participants in Arm C will receive the first cycle of RO7297089 as a single-step dose escalation. The Cycle 1 Day 1 dose will be lower than the target dose. The full target dose will be administered at subsequent study drug administration visits.
Drug: RO7297089
RO7297089 will be given via intravenous (IV) infusion

Experimental: Phase I Expansion Stage: RO7297089
After dose escalation has been completed, approximately 30 patients will be enrolled in the expansion stage. Participants will receive RO7297089 at the recommended phase 2 dose (at or below the maximum tolerated dose).
Drug: RO7297089
RO7297089 will be given via intravenous (IV) infusion




Primary Outcome Measures :
  1. Percentage of participants with Adverse Events (AEs), including Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline up to approximately 3 years ]
    Adverse event severity will be graded according to NCI CTCAE v5.0


Secondary Outcome Measures :
  1. Serum Concentration of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  2. Area under the Curve (AUC) of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  3. Maximum Concentration Observed (Cmax) of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  4. Time to Maximum Concentration Observed (tmax) of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  5. Minimum Concentration Observed (Cmin) of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  6. Volume of Distribution at Steady State of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  7. Half-life of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  8. Total clearance of RO7297089 [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit

  9. Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 3 years ]
    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

  10. Duration Of Response (DOR) [ Time Frame: Baseline up to approximately 3 years ]
    DOR is defined as the time from the first occurrence of a documented Objective Response to Disease Progression or death from any cause (whichever occurs first), as determined by the Investigator according to IMWG Uniform Response Criteria

  11. Prevalence Of Anti-Drug Antibodies (ADAs) [ Time Frame: Baseline up to approximately 3 years (detailed time frame provided in description) ]
    Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434469


Locations
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Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
Liverpool, New South Wales, Australia, 2170
Australia, South Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide, South Australia, Australia, 5000
St. Vincent's Hospital Melbourne
Fitzroy, South Australia, Australia, 3065
Australia, Victoria
Peter Mac Callum Cancer Center
East Melbourne, Victoria, Australia, 3002
Belgium
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Denmark
Rigshospitalet
København Ø, Denmark, 2100
Vejle Sygehus; Onkologisk Afdeling
Vejle, Denmark, 7100
Norway
Oslo Universitetssykehus HF; Ullevål sykehus
Oslo, Norway, 0450
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04434469    
Other Study ID Numbers: GO41582
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases