A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
- Registration Number
- NCT04557150
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 225
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part II: Dose Expansion Forimtamig 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. Part I: Dose Escalation Forimtamig Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Dose Limiting Toxicities (DLTs) Cycle 1 Day 1 up to Cycle 1 Day 35 Percentage of Participants with Adverse Events (AEs) Up to 104 weeks
- Secondary Outcome Measures
Name Time Method Time of Maximum Concentration (Tmax) of Forimtamig Up to 104 weeks Maximum Concentration (Cmax) of Forimtamig Up to 104 weeks Duration of Response (DOR) Up to 104 weeks SC Bioavailability (F) of Forimtamig Up to 104 weeks Volume of Distribution at Steady State (Vss) of Forimtamig (IV only) Up to 104 weeks Progression-Free Survival (PFS) Up to 104 weeks Overall Survival (OS) Up to 104 weeks Area Under the Curve (AUC) at Various Time Intervals of Forimtamig Up to 104 weeks Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig Up to 104 weeks Minimum Concentration (Cmin) of Forimtamig Up to 104 weeks Apparent Clearance (CL/F) of Forimtamig Up to 104 weeks Objective Response Rate (ORR) Up to 104 weeks
Trial Locations
- Locations (20)
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
UZ Gent
🇧🇪Gent, Belgium
Rigshospitalet
🇩🇰København Ø, Denmark
Odense Universitetshospital
🇩🇰Odense C, Denmark
CHRU Lille - Hôpital Claude Huriez
🇫🇷Lille, France
CHU NANTES - Hôtel Dieu
🇫🇷Nantes, France
Hopital De Haut Leveque
🇫🇷Pessac, France
IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica
🇮🇹Napoli, Campania, Italy
Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Emilia-Romagna, Italy
Fond. IRCCS Istituto Nazionale Tumori
🇮🇹Milano, Lombardia, Italy
Instituto Clinico Humanitas
🇮🇹Rozzano, Lombardia, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
New Zealand Clinical Research - Auckland
🇳🇿Auckland, New Zealand
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
St James University Hospital
🇬🇧Leeds, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom