A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06055075

Patient View

This study assesses the safety and anti-tumor activity of forimtamig, alone or with carfilzomib or daratumumab, in relapsed/refractory multiple myeloma. Participants must have an ECOG status of 0-1, a life expectancy of ≥12 weeks, and meet IMWG criteria for MM and progressive disease. The trial includes dose exploration and expansion phases, with forimtamig administered subcutaneously.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Documented diagnosis of MM according to the IMWG diagnostic criteria
  • Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
  • Measurable disease
  • AEs from prior anti-cancer therapy resolved to Grade ≤ 1,
  • Adequate organ functions

Exclusion Criteria

  • Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
  • Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL)
  • Participants with known amyloidosis
  • Participants with myelodysplastic syndrome
  • Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
  • Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration
  • Prior solid organ transplantation
  • Active auto-immune disease or flare within 6 months prior to start of study treatment
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Hepatitis B virus (HBV) infection
  • Acute or chronic hepatitis C virus (HCV) infection
  • Known history of HIV seropositivity
  • Live vaccine(s) within one month prior to start of the treatment
  • Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations
  • Previous refractoriness to carfilzomib
  • Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity
  • Participants with known liver cirrhosis
  • Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded

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