cibisatamab (RG7802)

Patients received cibisatamab with escalating doses of FAP-4-1BBL weekly or every 3 weeks after obinutuzumab pretreatment to mitigate anti-drug antibody formation. These findings demonstrate the feasibility of combining tumor antigen-directed T cell engagement with localized co-stimulation, with evidence of immune activation and preliminary antitumor activity supporting further clinical development. ClinicalTrials.gov identifier: NCT04826003 .

P1/2, N=314, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

For the assessment of the combination of CEA-TCB with CEA-4-1BBL, co-stimulatory antibody fusion protein in vitro assays are not sufficient to fully capture the complex relationships affecting efficacy. Thus, screening with different cell assays and in vivo efficacy studies in combination with CEA-TCB are essential to select the best candidate. Based on the totality of data on the T84.66-LCHA-4-1BBL antibody fusion protein comprising the CEACAM5 antibody, T84.66-LCHA was selected as the optimal combination partner for CEA-TCB.

P1/2, N=314, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Nov 2026 --> Nov 2025

P1, N=54, Completed, Hoffmann-La Roche | Phase classification: P1/2 --> P1

This highlights our model's potential to predict clinical immunotherapy outcomes, capturing complex responses like immune activation, therapeutic selectivity, and potential resistance mechanisms. These findings underscore the utility of our model as a reliable, physiologically relevant tool for screening new immunotherapies and advancing our understanding of tumor-immune dynamics.

P1/2, N=54, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=80 --> 54

P1/2, N=314, Active, not recruiting, Hoffmann-La Roche | N=675 --> 314

P1, N=47, Terminated, Hoffmann-La Roche | Completed --> Terminated; The Sponsor terminated the study because development of cibisatamab has been discontinued.

P1/2, N=675, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2026 --> Sep 2025 | Recruiting --> Active, not recruiting | Trial completion date: Sep 2027 --> Nov 2026

Cibisatamab is a bispecific antibody-based construct targeting carcinoembryonic antigen (CEA) on tumour cells and CD3 epsilon chain as a T-cell engager. ADA appearance could be mitigated by obinutuzumab-pretreatment, with 8% of patients having persistent ADAs. Overall, cibisatamab warrants further exploration in immunotherapy combination strategies for MSS-CRC.

P1, N=47, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed