Back to resultsA Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Primary Purpose
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7297089
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
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
Sites / Locations
- Concord Repatriation General Hospital
- LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
- Royal Adelaide Hospital; Haematology Clinical Trials
- St. Vincent's Hospital Melbourne
- Peter Mac Callum Cancer Center
- UZ Gent
- UZ Leuven
- Rigshospitalet
- Vejle Sygehus; Onkologisk Afdeling
- Oslo Universitetssykehus HF; Ullevål sykehus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm A Flat Dose Escalation: RO7297089
Arm B Split Dose Escalation: RO7297089
Arm C Step Dose Escalation: RO7297089
Phase I Expansion Stage: RO7297089
Arm Description
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
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.
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.
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).
Outcomes
Primary Outcome Measures
Percentage of participants with Adverse Events (AEs), including Dose Limiting Toxicities (DLTs)
Adverse event severity will be graded according to NCI CTCAE v5.0
Secondary Outcome Measures
Serum Concentration of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Area under the Curve (AUC) of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Maximum Concentration Observed (Cmax) of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Time to Maximum Concentration Observed (tmax) of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Minimum Concentration Observed (Cmin) of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Volume of Distribution at Steady State of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Half-life of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Total clearance of RO7297089
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Objective Response Rate (ORR)
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
Duration Of Response (DOR)
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
Prevalence Of Anti-Drug Antibodies (ADAs)
Cycles 1, 2, 3, 4, 6, 8, and then every 6 cycles, Day 1 of any intrapatient dose escalation, and at Treatment Discontinuation Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04434469
Brief Title
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A Flat Dose Escalation: RO7297089
Arm Type
Experimental
Arm Description
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Arm Title
Arm B Split Dose Escalation: RO7297089
Arm Type
Experimental
Arm 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.
Arm Title
Arm C Step Dose Escalation: RO7297089
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase I Expansion Stage: RO7297089
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
RO7297089
Intervention Description
RO7297089 will be given via intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Percentage of participants with Adverse Events (AEs), including Dose Limiting Toxicities (DLTs)
Description
Adverse event severity will be graded according to NCI CTCAE v5.0
Time Frame
Baseline up to approximately 3 years
Secondary Outcome Measure Information:
Title
Serum Concentration of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Area under the Curve (AUC) of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Maximum Concentration Observed (Cmax) of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Time to Maximum Concentration Observed (tmax) of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Minimum Concentration Observed (Cmin) of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Volume of Distribution at Steady State of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Half-life of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Total clearance of RO7297089
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
Title
Objective Response Rate (ORR)
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
Time Frame
Baseline up to approximately 3 years
Title
Duration Of Response (DOR)
Description
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
Time Frame
Baseline up to approximately 3 years
Title
Prevalence Of Anti-Drug Antibodies (ADAs)
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
Time Frame
Baseline up to approximately 3 years (detailed time frame provided in description)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Adelaide Hospital; Haematology Clinical Trials
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
South Australia
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peter Mac Callum Cancer Center
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Vejle Sygehus; Onkologisk Afdeling
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Oslo Universitetssykehus HF; Ullevål sykehus
City
Oslo
ZIP/Postal Code
0450
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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)
Learn more about this trial
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
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