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

Launched by BICARA THERAPEUTICS · Jan 17, 2025

Keywords

ClinConnect Summary

The FORTIFI-HN01 clinical trial is studying a new treatment called ficerafusp alfa, which targets two specific proteins in the body, in combination with another medication called pembrolizumab. This trial focuses on patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have a certain marker called PD-L1. Essentially, the researchers want to find out if this new treatment is safe and more effective than a placebo (a non-active treatment) when used with pembrolizumab.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of recurrent or metastatic HNSCC in specific areas of the mouth or throat. They should not have received prior systemic treatments for their cancer recently. Participants can expect to undergo some tests to check their overall health and cancer status. It's important to note that those with certain health conditions or previous treatments may not qualify for the study. If you or someone you know is considering this trial, it could be a chance to access a potentially promising treatment option while contributing to important research in cancer care.

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Eligibility criteria

• 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 (by PD-L1 IHC 22C3 pharmDx assay).
• • 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.
• • Other Inclusion/Exclusion criteria may apply as defined in the protocol.