Recruiting
Phase 2

Ficerafusp Alfa & Pembrolizumab

Sponsor:

Bicara Therapeutics

Code:

NCT07807163

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ficerafusp alfa

Pembrolizumab (KEYTRUDA®)

Study Details

Brief summary:

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).

The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Study ID

NCT07807163

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Loading phase (12 weeks): Ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.

Maintenance phase: Ficerafusp alfa 2250 mg Q3W (alternative dose) + pembrolizumab 200 mg Q3W.

experimental: Arm B

Continuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.

Interventions

Ficerafusp alfa

investigational agent

Pembrolizumab (KEYTRUDA®)

immunotherapy agent used in combination with investigational agent

Primary outcome measure

  • Proportion of participants in maintenance phase who are progression-free as assessed by blinded independent central review (BICR) per RECIST 1.1 and alive. [ Time Frame: Approximately 9 months. ]

Central Contacts and Locations

Central contacts

Medical Affairs

1-617-468-4219FORTIFI_inquiries@bicara.com

Locations

Site US077

Recruiting

Fort Myers, Florida, United States, 33980

Site US078

Recruiting

Orlando, Florida, United States, 32827

Site US075

Recruiting

St. Petersburg, Florida, United States, 33701

Site US076

Recruiting

West Palm Beach, Florida, United States, 33410

Site US069

Recruiting

Baton Rouge, Louisiana, United States, 70809

Site US074

Recruiting

Tyler, Texas, United States, 75702

Site US073

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

Bicara Therapeutics

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • head and neck cancer
  • HNSCC
  • recurrent HNSCC
  • metastatic HNSCC
  • first line treatment
  • Phase 2
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Pembrolizumab
  • PD-L1+
  • TGF-beta
  • oral cavity
  • oropharynx
  • larynx
  • hypopharynx
  • Ficerafusp alfa
  • SCCHN
  • HPVneg
  • HPV negative
  • HPV-
  • BCA101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Bicara Therapeutics on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.