Status:
RECRUITING
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Lead Sponsor:
Bicara Therapeutics
Conditions:
Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ficeraf...
Detailed Description
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 identif...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT06788990
Start Date
January 28 2025
End Date
July 1 2029
Last Update
March 5 2026
Active Locations (125)
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1
Site # 0137
Birmingham, Alabama, United States, 35233
2
Site #0147
Phoenix, Arizona, United States, 85054
3
Site #0107
La Jolla, California, United States, 92093
4
Site #0106
Los Angeles, California, United States, 90095