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NCT Number: NCT06055075

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

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.

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Key information

Conditions

Relapsed or Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Alexandra Hospital Woolloongabba, Woolloongabba, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forimtamig

Drug

Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.

Carfilzomib

Drug

Carfilzomib will be administered via IV infusion in combination with forimtamig.

Daratumumab

Drug

Daratumumab will be administered via SC injection in combination with forimtamig.

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 24 months

  2. Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria

    Time frame: Up to approximately 24 months

  3. Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  4. Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  2. Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  3. Time to First Response as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  4. Time to Best Response as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  5. Overall Survival (OS) as Determined by the Investigator per IMWG Criteria

    Time frame: Up to approximately 24 months

  6. Serum Concentration of Forimtamig

    Time frame: Up to approximately 24 months

  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig

    Time frame: Up to approximately 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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