A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participa… (NCT04557150) | Clinical Trial Compass
CompletedPhase 1
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
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).
Who can participate
Age range18 Years
SexALL
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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.
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 a…
What they're measuring
1
Percentage of Participants with Adverse Events (AEs)
Timeframe: Up to 104 weeks
2
Percentage of Participants with Dose Limiting Toxicities (DLTs)