About this trial
This is a multicenter, randomized, double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.
The mechanism of action of ficerafusp alfa involves dual targeting of two cancer targets, EGFR and TGF-β, which are known to drive solid tumor growth and metastasis.
Phase 2 of the study will identify an optimal biologic dose (OBD) supported by the safety, tolerability, PK, PD, and efficacy data of ficerafusp alfa. In this part, eligible subjects will be randomized to one of three treatment arms at a 1:1:1 ratio:
Arm A: ficerafusp alfa 1500 mg once weekly (QW) + pembrolizumab 200 mg every three weeks (Q3W).
Arm B: ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W.
Arm C (control): placebo QW + pembrolizumab 200 mg Q3W.
The primary objective for the phase 3 portion is to compare the efficacy in subjects treated with ficerafusp alfa at the selected OBD in combination with pembrolizumab versus placebo with pembrolizumab. Eligible subjects will be randomized 2:1 in the treatment versus control arm during the phase 3 portion.
Patient Profile
Adult patients with hystologically or cytologically confirmed Recurrent or Metastatic HNSCC. Eligible primary locations in the oral cavity, hypopharynx, larynx, or oropharynx (with documented HPV-negative disease if presenting with OPSCC) and a documented tumor PD-L1 CPS ≥1 with no prior systemic therapies in the recurrent or metastatic setting.
Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Where’s this trial being run?
Beaumont Hospital, Cork University Hospital, and St James’s Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | FORTIFI-HN01 (BCA101X301) |
|---|---|
| Number: | 25-07 |
| Full Title: | FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC (FORTIFI-HN01) |
| Principal Investigator: | Dr Cliona Grant |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | BicaraTherapeutics Inc |
| Recruitment Started: |
Global: Dec 2025 Ireland: Jan 2025 |
| Global Recruitment Target: | 687 |
|---|---|
| Ireland Recruitment Target: |