Clinical trials

3

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

Condition / disease
Location
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: 473
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Bicara TherapeuticsUpdated: Oct 6, 2026Locations: 21
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]

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: Oct 2, 2026Locations: 231
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

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).

Participants needed: 160
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Bicara TherapeuticsUpdated: Sep 8, 2026Locations: 1
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]