Skip to main content
OpenTrials
Completed

NCT Number: NCT04557150

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Center, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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 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.

Treatment and study plan

Forimtamig

Drug

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.

Other names: RO7425781

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to 104 weeks

  2. Percentage of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Cycle 1 Day 1 up to Cycle 1 Day 35

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 104 weeks

  2. Duration of Response (DOR)

    Time frame: Up to 104 weeks

  3. Progression-Free Survival (PFS)

    Time frame: Up to 104 weeks

  4. Overall Survival (OS)

    Time frame: Up to 104 weeks

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

    Time frame: Up to 104 weeks

  6. Maximum Concentration (Cmax) of Forimtamig

    Time frame: Up to 104 weeks

  7. Time of Maximum Concentration (Tmax) of Forimtamig

    Time frame: Up to 104 weeks

  8. Minimum Concentration (Cmin) of Forimtamig

    Time frame: Up to 104 weeks

  9. SC Bioavailability (F) of Forimtamig

    Time frame: Up to 104 weeks

  10. Apparent Clearance (CL/F) of Forimtamig

    Time frame: Up to 104 weeks

  11. Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)

    Time frame: Up to 104 weeks

  12. Area Under the Curve (AUC) at Various Time Intervals of Forimtamig

    Time frame: Up to 104 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2020
Registry last updated
Apr 13, 2026

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.

Published trials that share one or more normalized conditions with this study.