OnCo
drugsProductPhase 3

Ficerafusp alfa

Ficerafusp alfa is an EGFR antibody fused to a TGF-beta sponge, designed to remove the immune-suppressing signal that keeps HPV-negative throat cancers cold.

Ficerafusp alfa is developed by Bicara Therapeutics. Phase 1/1b with pembrolizumab in HPV-negative first-line HNSCC showed durable responses at two years (JCO 2025). FORTIFI-HN01 phase 2/3 fixed the dose at 1500 mg; interim analysis expected mid-2027.

Schematic of the modality · Bifunctional antibody (EGFR × TGF-β trap) · not a molecule; see the Bispecific antibodies page
Mechanism, step by step
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1.Binds EGFR on tumour cells, localising the molecule to the tumour

Modality
Bifunctional antibody (EGFR × TGF-β trap)
Mechanism
Anti-EGFR IgG1 with a TGF-βRII extracellular domain fused to the heavy chain, neutralising TGF-β locally.
Brand / code
BCA101
Dosing & schedule
Route
Intravenous
Schedule
1500 mg every 2 weeks with pembrolizumab

Source: clinicaltrials.gov/study/NCT06788990. Doses are for orientation; the current label governs.

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Ficerafusp alfa
intervention: Ficerafusp alfa
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Landmark trials in OnCo

Latest papers

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Literature trend6 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Ficerafusp alfa" OR ABSTRACT:"Ficerafusp alfa" OR TITLE:"BCA101" OR ABSTRACT:"BCA101") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ficerafusp alfa, not a curated reading list.

Connected

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