In short
Ficerafusp alfa is an investigational protein-based substance being studied for recurrent or metastatic head and neck squamous cell carcinoma. It has no marketing authorisation and is given by intravenous infusion in clinical trials. Two authorised trials are testing it: a Phase 2 study with 121 participants and a Phase 4 study with 676 participants, both in combination with other cancer medicines.
Key points
- Ficerafusp alfa is an investigational antibody therapy with no marketing authorisation.
- It is being studied in recurrent or metastatic head and neck squamous cell carcinoma.
- One trial is in Phase 2 with 121 participants; the other is in Phase 4 with 676 participants.
- Both trials combine ficerafusp alfa with pembrolizumab or nivolumab.
- The main measure is objective response rate (ORR), meaning how many participants' tumours shrink or disappear.
- Ficerafusp alfa is given as a solution for infusion into a vein.
What is ficerafusp alfa?
Ficerafusp alfa is a protein-based substance, specifically a therapeutic antibody, classified in the therapeutic area of neoplasms (cancers). It is also known by the development code BCA 101. The substance has no marketing authorisation in the product records, which means it is still an investigational medicine. The company BICARA is listed as the authorisation holder for the investigational product.
How does ficerafusp alfa work?
The available registry records do not describe the molecular mechanism of action of ficerafusp alfa. As a protein-based antibody substance, it is designed to target specific molecules involved in cancer growth, but the exact target is not stated in the trial data provided.
Which conditions is ficerafusp alfa studied for?
- Recurrent or metastatic head and neck squamous cell carcinoma — a cancer of the head and neck that has come back after treatment or spread to other parts of the body.
- Platinum-refractory head and neck squamous cell carcinoma — a form of head and neck cancer that no longer responds to platinum-based chemotherapy and has progressed within 6 months after treatment for locally advanced disease.
How is ficerafusp alfa given?
Ficerafusp alfa is prepared as a solution for infusion and is given intravenously, meaning it is administered directly into a vein. The pharmaceutical form listed in the registry is a vial for intravenous use. In the trials, ficerafusp alfa is given at doses of 1500 mg or 750 mg, once weekly, in combination with other cancer medicines.
What do the clinical trials show?
Two trials of ficerafusp alfa are listed in the registries, both in head and neck squamous cell carcinoma. One is a Phase 2 study with 121 participants, and the other is a Phase 4 study with 676 participants. Both trials are authorised, meaning they have received regulatory approval to proceed but may not yet be recruiting.
Which phases and status do the trials have?
The Phase 2 trial (2025-521437-88-00) is authorised and plans to enrol 121 participants. The Phase 4 trial (NCT06788990) is authorised and plans to enrol 676 participants. Phase 4 trials are typically conducted after a medicine has been approved, but in this case the substance still has no marketing authorisation, so this trial design is unusual and may reflect a combined Phase 2/Phase 3 design described in the trial summary.
What are the trials measuring?
The Phase 2 trial measures objective response rate (ORR), which is the proportion of participants whose tumours shrink by a defined amount (complete response or partial response) according to RECIST criteria 1.1. The Phase 4 trial has a dose-selection phase measuring safety, tolerability and ORR, followed by a Phase 3 part measuring overall survival (OS) — the time from randomisation to death from any cause — and ORR.
Who can take part in these trials?
Both trials enrol people with head and neck squamous cell carcinoma. The Phase 2 trial is for patients with platinum-refractory disease that progressed within 6 months after multimodality treatment for locally advanced disease. The Phase 4 trial includes participants with recurrent or metastatic head and neck squamous cell carcinoma.
What side effects are known?
The trial registries do not report side effects from completed studies. The Phase 4 trial lists safety measures including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as outcomes to be assessed, but no results are yet available.