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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
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.
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
UZ Gent
Ghent, Belgium
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 104 weeks
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 up to Cycle 1 Day 35
Objective Response Rate (ORR)
Time frame: Up to 104 weeks
Duration of Response (DOR)
Time frame: Up to 104 weeks
Progression-Free Survival (PFS)
Time frame: Up to 104 weeks
Overall Survival (OS)
Time frame: Up to 104 weeks
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
Time frame: Up to 104 weeks
Maximum Concentration (Cmax) of Forimtamig
Time frame: Up to 104 weeks
Time of Maximum Concentration (Tmax) of Forimtamig
Time frame: Up to 104 weeks
Minimum Concentration (Cmin) of Forimtamig
Time frame: Up to 104 weeks
SC Bioavailability (F) of Forimtamig
Time frame: Up to 104 weeks
Apparent Clearance (CL/F) of Forimtamig
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Naples, Campania, Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Fond. IRCCS Istituto Nazionale Tumori
Milan, Lombardy, Italy
...and 10 more locations
Time frame: Up to 104 weeks
Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)
Time frame: Up to 104 weeks
Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
Time frame: Up to 104 weeks