OnCo
drugsProductPhase 3

Brenetafusp

Tebentafusp's successor: a soluble T-cell receptor that recognises a fragment of PRAME, a protein present in most melanomas and many other cancers, and drags T cells onto the tumour.

Phase 1/2 in heavily pretreated cutaneous melanoma: median OS 14.3 months on monotherapy (ASCO 2026 update). PRISM-MEL-301 phase 3 with nivolumab in first-line HLA-A*02:01-positive melanoma is enrolling; further trials in ovarian, lung, and endometrial cancer. Requires HLA-A*02:01 (roughly half of European-ancestry patients).

Schematic of the modality · ImmTAC (PRAME TCR × CD3 bispecific) · not a molecule; see the T-cell engagers (bispecific) page
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Mechanism, step by step
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1.The TCR arm binds PRAME peptide displayed on HLA-A*02:01 on the tumour cell

Modality
ImmTAC (PRAME TCR × CD3 bispecific)
Mechanism
Affinity-enhanced TCR binding PRAME peptide–HLA-A*02:01 fused to an anti-CD3 scFv; redirects polyclonal T cells.
Brand / code
IMC-F106C
Dosing & schedule
Route
Intravenous
Schedule
Weekly with step-up dosing to 160 µg
Monitoring
Cytokine release syndrome during the first doses; rash

Source: clinicaltrials.gov/study/NCT06112314. Doses are for orientation; the current label governs.

Regulatory

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  1. 2024DesignationUS

    Phase 3 PRISM-MEL-301 initiated after FDA alignment on design

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
3 studies1 recruiting2 Phase 21 Phase 3
Search “Brenetafusp” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Brenetafusp
intervention: Brenetafusp
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend1 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Brenetafusp" OR ABSTRACT:"Brenetafusp" OR TITLE:"IMC-F106C" OR ABSTRACT:"IMC-F106C") 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 Brenetafusp, not a curated reading list.

Connected

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