Clinical trials
catalyst calendar across sponsors →Studies where BCAX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
2 interventional
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCCNCT06788990Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.Randomized · Double-masked · Treatment | Phase 2/3 | Recruiting | Drug: Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo | Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | 650 | Apr 2028 | ≤ 620 d | 2026-07-17 |
| Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid TumorsNCT04429542Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEsNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: BCA101, Pembrolizumab | Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung, EGFR Amplification, Epithelial Ovarian Cancer, Pancreas Cancer, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck | 292 | 2026-12-31 | in 134 d | 2025-08-15 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19