Clinical trials

2

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
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

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 ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Participants needed: 650
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Bicara TherapeuticsUpdated: Jun 2, 2026Locations: 173
Eligibility criteria

Age ≥18 years on the day the Informed Consent Form is signed. [+7]

Disease suitable for local therapy administered with curative intent. [+17]

Status: Recruiting

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Participants needed: 292
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Bicara TherapeuticsUpdated: Aug 15, 2025Locations: 20
Eligibility criteria

Patient must have measurable disease amendable to biopsy and be willing to under... [+5]

For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of... [+8]