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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04557150
Registration number
NCT04557150
Ethics application status
Date submitted
17/09/2020
Date registered
21/09/2020
Date last updated
28/05/2024
Titles & IDs
Public title
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
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Scientific title
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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2020-002012-46
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Secondary ID [2]
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BP42233
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Forimtamig
Experimental: Part I: Dose Escalation - Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
Experimental: Part II: Dose Expansion - Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.
Treatment: Drugs: Forimtamig
Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to 104 weeks
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Primary outcome [2]
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Percentage of Participants with Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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Timepoint [2]
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Cycle 1 Day 1 up to Cycle 1 Day 35
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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Timepoint [1]
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Up to 104 weeks
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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Timepoint [2]
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Up to 104 weeks
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Secondary outcome [3]
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Progression-Free Survival (PFS)
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Assessment method [3]
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Timepoint [3]
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Up to 104 weeks
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Timepoint [4]
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Up to 104 weeks
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Secondary outcome [5]
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Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
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Assessment method [5]
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Timepoint [5]
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Up to 104 weeks
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Secondary outcome [6]
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Maximum Concentration (Cmax) of Forimtamig
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Assessment method [6]
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Timepoint [6]
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Up to 104 weeks
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Secondary outcome [7]
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Time of Maximum Concentration (Tmax) of Forimtamig
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Assessment method [7]
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Timepoint [7]
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Up to 104 weeks
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Secondary outcome [8]
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Minimum Concentration (Cmin) of Forimtamig
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Assessment method [8]
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Timepoint [8]
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Up to 104 weeks
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Secondary outcome [9]
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SC Bioavailability (F) of Forimtamig
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Assessment method [9]
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Timepoint [9]
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Up to 104 weeks
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Secondary outcome [10]
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Apparent Clearance (CL/F) of Forimtamig
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Assessment method [10]
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Timepoint [10]
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Up to 104 weeks
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Secondary outcome [11]
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Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)
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Assessment method [11]
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Timepoint [11]
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Up to 104 weeks
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Secondary outcome [12]
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Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
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Assessment method [12]
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Timepoint [12]
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Up to 104 weeks
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Eligibility
Key inclusion criteria
- Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
- Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have
previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome
Inhibitor (PI) and are intolerant to or have no other option for standard-of-care
treatment according to the Investigator.
- Life expectancy of at least 12 weeks.
- Agreement to provide protocol-specific biopsy material.
- AEs from prior anti-cancer therapy resolved to Grade =<1.
- Measurable disease.
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse), use contraceptive measures and refrain from
donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual
intercourse), use contraceptive measures and refrain from donating sperm.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Inability to comply with protocol-mandated hospitalization and activities
restrictions.
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3
months after last dose of study drug.
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate
for MM treatment within 2 weeks before first forimtamig administration.
- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first
forimtamig administration.
- Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first
forimtamig administration. Limited field palliative radiotherapy for bone pain or for
soft tissue lesions is allowed.
- Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to
first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing
immunosuppressive medication.
- Prior solid organ transplantation.
- Active auto-immune disease or flare within 6 months prior to start of study treatment
- Any medical condition or abnormality in clinical laboratory tests that, in the
Investigator's or Medical Monitor's judgment, precludes the participant's safe
participation in and completion of the study, or which could affect compliance with
the protocol or interpretation of results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/08/2026
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Actual
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Sample size
Target
480
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Center - North Melbourne
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Recruitment postcode(s) [1]
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3051 - North Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Gent
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Denmark
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State/province [2]
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København Ø
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Country [3]
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Denmark
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State/province [3]
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Odense C
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Country [4]
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France
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State/province [4]
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Lille
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Country [5]
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France
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State/province [5]
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Nantes
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Country [6]
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France
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State/province [6]
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Pessac
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Country [7]
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Italy
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State/province [7]
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Campania
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Italy
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State/province [8]
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Emilia-Romagna
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Italy
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State/province [9]
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Lombardia
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Country [10]
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Korea, Republic of
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State/province [10]
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Seoul
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Country [11]
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New Zealand
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State/province [11]
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Auckland
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Country [12]
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Spain
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State/province [12]
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Cantabria
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Country [13]
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Spain
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State/province [13]
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Navarra
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Country [14]
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Spain
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State/province [14]
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Salamanca
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Country [15]
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United Kingdom
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State/province [15]
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Leeds
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Country [16]
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United Kingdom
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State/province [16]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy,
dose-escalation and dose expansion study. Forimtamig will be administered to participants
with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those
established therapies. The study consists of two parts: dose-escalation of forimtamig (Part
1) and a randomized dose expansion of forimtamig (Part 2).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04557150
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: BP42233 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. and Canada)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04557150
Download to PDF