COMPANY

Bicara Therapeutics

Location: Boston, MA · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Metastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma 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 Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck BCA101

$172.5MRaised (2 yrs)3Trials (company is sponsor)

Timeline

2026-09 Trial start Phase 2: A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC source ↗
Feb 26, 2026 Raise Follow-on offering: $172.5M (total, as published), announced Feb 26, 2026. Source: company release on GlobeNewswire. source ↗
Jan 28, 2025 Trial start Phase 2/Phase 3: FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC source ↗
Jun 1, 2020 Trial start Phase 1: Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors source ↗

Upcoming milestones

Oct 31, 2027 (ESTIMATED) · Phase 1 · Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors · NCT04429542
2028-03 (ESTIMATED) · Phase 2 · A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC · NCT07807163
2028-04 (ESTIMATED) · Phase 2/Phase 3 · FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC · NCT06788990

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $172.5M. Last 2 years.

Feb 26, 2026 Follow-on offering: $172.5M (total, as published), announced Feb 26, 2026. Source: company release on GlobeNewswire. source ↗

Clinical trials (lead sponsor) 3

Record	Title	Phase	Status	Start	Primary completion
NCT04429542	Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors	Phase 1	Recruiting	Jun 1, 2020	Oct 31, 2027 (estimated)
NCT06788990	FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC	Phase 2/Phase 3	Recruiting	Jan 28, 2025	2028-04 (estimated)
NCT07807163	A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC	Phase 2	Recruiting	2026-09	2028-03 (estimated)