A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC

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).

Trial Details

NCT ID
NCT07807163
Phase
PHASE2
Sponsor
Bicara Therapeutics
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Ficerafusp alfa
  • Pembrolizumab (KEYTRUDA®)
Locations (sample)
  • Fort Myers, Florida, United States|26.62168,-81.84059
  • Orlando, Florida, United States|28.53834,-81.37924
  • St. Petersburg, Florida, United States|27.77086,-82.67927
  • West Palm Beach, Florida, United States|26.71534,-80.05337
  • Baton Rouge, Louisiana, United States|30.44332,-91.18747

Key Eligibility 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 d…
  • No prior systemic therapy administered in the R or M setting; and completed systemic therapy \>6 months prior if given as part of multimodal treatm…
  • Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.

For full eligibility, visit ClinicalTrials.gov.

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