FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

In brief

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Key facts

Study ID: NCT06788990
Run by: Bicara Therapeutics
People needed: 650
Starts: 2025-01-28
Expected to finish: 2029-07-01
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years on the day the Informed Consent Form is signed.
Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
No prior systemic therapy administered in the R or M setting; and completed systemic therapy >6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.
Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.
PD-L1 CPS ≥1.
Measurable disease based on RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function, as defined in the protocol.

You may not qualify if…

Disease suitable for local therapy administered with curative intent.
Prior treatment with anti-TGFβ therapy.
Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
Progressive disease <6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
Life expectancy less than 3 months.
Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
Active autoimmune disease requiring systemic treatment in the past 2 years.
Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
Known history of human immunodeficiency virus (HIV).
Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Where it is running

Site #0147 — Phoenix, Arizona, United States (enrolling)
Site #0107 — La Jolla, California, United States (enrolling)
Site #0106 — Los Angeles, California, United States (enrolling)
Site#0144 — Sacramento, California, United States (enrolling)
Site #0130 — San Francisco, California, United States (enrolling)
Site #0150 — Stanford, California, United States (enrolling)
Site #0122 — Aurora, Colorado, United States (enrolling)
Site #0124 — Aurora, Colorado, United States (enrolling)
Site#0121 — Aurora, Colorado, United States (enrolling)
Site #0148 — Jacksonville, Florida, United States (enrolling)
Site #0136 — Palm Bay, Florida, United States (enrolling)
Site #0105 — Tampa, Florida, United States (enrolling)
Site#0140 — Iowa City, Iowa, United States (enrolling)
Site #0149 — Westwood, Kansas, United States (enrolling)
Site#0111 — Louisville, Kentucky, United States (enrolling)
Site#0115 — Louisville, Kentucky, United States (enrolling)
Site #0112 — Baltimore, Maryland, United States (enrolling)
Site #0131 — Boston, Massachusetts, United States (enrolling)
Site#0101 — Boston, Massachusetts, United States (enrolling)
Site #0156 — Maplewood, Minnesota, United States (enrolling)
Site #0146 — Rochester, Minnesota, United States (enrolling)
Site #0114 — St Louis, Missouri, United States (enrolling)
Site #0145 — Newark, New Jersey, United States (enrolling)
Site #0155 — New York, New York, United States (enrolling)
Site # 0137 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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