Faron Pharmaceuticals has announced that the first patient has been enrolled in the Phase 1b/2 BEXAR trial, evaluating bexmarilimab plus doxorubicin as first-line treatment for patients with metastatic soft-tissue sarcoma.
The investigator-initiated study represents the first clinical evaluation of bexmarilimab combined with chemotherapy in a solid tumor and the first assessment of an anti-Clever-1 strategy together with doxorubicin in soft-tissue sarcoma.
BEXAR Trial Design
Sponsored by MEDSIR, BEXAR is being conducted at six hospitals across Spain and is led by Vall d’Hebron University Hospital in Barcelona.
The Phase 1b portion will evaluate the safety and tolerability of bexmarilimab in combination with doxorubicin. This will be followed by a contingent randomized Phase 2 stage evaluating preliminary efficacy of the combination compared with doxorubicin alone. The trial is registered as NCT07460986.
Targeting an Immunosuppressive Tumor Microenvironment
Soft-tissue sarcomas are a diverse group of aggressive malignancies for which treatment options remain limited, particularly in the metastatic setting.
Many subtypes are characterized by an immunologically inactive tumor microenvironment dominated by immunosuppressive macrophages. According to Faron, these tumors can express particularly high levels of Clever-1, the receptor targeted by bexmarilimab, providing a biological rationale for combining the drug with chemotherapy.
“Metastatic soft-tissue sarcoma has seen limited therapeutic progress in decades, and remains particularly difficult to treat,” said César Serrano, Group Leader of the Sarcoma Translational Research Program at the Vall d’Hebron Institute of Oncology and scientific and clinical lead of the trial.
He added that the study aims to determine whether reprogramming immunosuppressive macrophages with bexmarilimab can help trigger an antitumor response and translate into clinical benefit when combined with doxorubicin.
About Bexmarilimab
Bexmarilimab is Faron’s investigational humanized antibody targeting Clever-1, a receptor expressed on immunosuppressive macrophages that can contribute to cancer immune evasion.
By blocking Clever-1, the therapy is designed to reprogram myeloid cells and alter the tumor microenvironment in a way that promotes antitumor immune activity.
Petri Bono, Chief Medical Officer at Faron, said:
“The initiation of patient enrollment in the BEXAR trial is a significant milestone for our solid tumor strategy.”
According to Bono, evidence of synergy between bexmarilimab and chemotherapy could also provide a rationale for evaluating the drug with other chemotherapy backbones across additional Clever-1-expressing tumor types.
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