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    DRUG:

    forimtamig (RG6234)

    i
    Other names: RG6234, RG-6234, RO7425781, RG 6234, RO-7425781, RO 7425781
    Associations

    News

    Trials
    Company:
    Roche
    Drug class:
    CD3 agonist, GPRC5D inhibitor
    Related drugs:
    Associations

    News

    Trials
    5ms
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=19, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Trial completion
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    6ms
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=19, Active, not recruiting, Hoffmann-La Roche | N=316 --> 19
    Enrollment change
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    9ms
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=316, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jun 2027 --> Apr 2025
    Trial completion date
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    1year
    BP42233: A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM) (clinicaltrials.gov)
    P1, N=225, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | N=480 --> 225 | Trial completion date: Aug 2026 --> Feb 2026 | Trial primary completion date: Aug 2026 --> Feb 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    forimtamig (RG6234)
    1year
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=316, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2027 --> Apr 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    1year
    Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. (PubMed, Blood)
    Forimtamig is currently being evaluated in Phase 1 clinical trials in relapsed and refractory myeloma (RRMM) patients for monotherapy and in combination treatments. NCT04557150.
    Journal
    |
    CRBN (Cereblon)
    |
    forimtamig (RG6234)
    over1year
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=316, Recruiting, Hoffmann-La Roche | Phase classification: P1 --> P1/2
    Phase classification
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    2years
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=316, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    2years
    Early Intervention with Celmods, but Not Imids, Prevents Relapse to Forimtamig Driven By GPRC5D-Negative Myeloma Cells (ASH 2023)
    To evaluate if cereblon modulation represents a strategy to improve PFS, we combined fixed-duration forimtamig with either pomalidomide (pom) or iberdomide (iber) at C1 day 1 (C1D1). Taken together, our data suggest that combination with CELMoDs but not IMIDs can prevent relapse to forimtamig driven by GPRC5D negative tumor cells. We confirm timing of intervention with CELMoDs to have an significant impact on PFS and cytokine release and suggest a broad therapeutic window using low dose forimtamig and intermittent dosing of iberdomide or mezigdomide.
    IO biomarker
    |
    IFNG (Interferon, gamma) • CRBN (Cereblon) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2 (Interleukin 2) • GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D) • CCL3 (C-C Motif Chemokine Ligand 3)
    |
    GPRC5D expression
    |
    pomalidomide • iberdomide (CC-220) • mezigdomide (CC-92480) • forimtamig (RG6234)
    2years
    Co-Expression of GPRC5D, FcRH5 and BCMA Suggests That Targeting More Than One Cell Surface Marker May be a Viable Strategy in Relapsed/Refractory Multiple Myeloma (RRMM): Biomarker Results from the Phase I Study of Forimtamig, a GPRC5DxCD3 Bispecific Antibody (ASH 2023)
    GPRC5D, FcRH5 and BCMA are highly prevalent across MM patient subgroups, including high-risk patients who may warrant targeted therapy approaches. Based on our data and previously published work for FcRH5- and BCMA-targeted T-cell bispecifics (Sumiyoshi et al. EHA 2021; Cortes-Selva et al.
    P1 data • IO biomarker
    |
    GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)
    |
    GPRC5D overexpression • GPRC5D expression
    |
    forimtamig (RG6234)
    2years
    A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=316, Not yet recruiting, Hoffmann-La Roche | Phase classification: P1/2 --> P1
    Phase classification
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
    2years
    Combination of forimtamig with standard of care improves depth and duration of response in preclinical models of multiple myeloma (IMW 2023)
    Synergistic anti-tumoral and NK stimulatory effects suggest a benefit of daratumumab combination in patients with high tumor burden and high risk of developing CRS. Broad immunomodulatory effects of pomalidomide could help sustain T cell responses in patients but may increase the risk of CRS. Considering the importance of balancing CRS and efficacy, carfilzomib was identified as another promising combination partner for forimtamig.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2RA (Interleukin 2 receptor, alpha) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • TNFRSF9 (TNF Receptor Superfamily Member 9) • LAMP1 (Lysosomal Associated Membrane Protein 1) • GZMA (Granzyme A) • CCL3 (C-C Motif Chemokine Ligand 3)
    |
    LAMP1 expression
    |
    Darzalex (daratumumab) • carfilzomib • pomalidomide • forimtamig (RG6234)