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First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

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Trial Profile

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Ficerafusp alfa (Primary) ; Pembrolizumab (Primary)
  • Indications Advanced breast cancer; Anal cancer; Carcinoma; Chordoma; Colorectal cancer; Gastric cancer; Glioblastoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Liver cancer; Lung cancer; Mouth neoplasm; Non-small cell lung cancer; Oropharyngeal cancer; Ovarian cancer; Pancreatic cancer; Pharyngeal neoplasms; Skin cancer; Solid tumours; Squamous cell cancer; Uveal melanoma
  • Focus Adverse reactions; First in man
  • Sponsors Bicara Therapeutics

Most Recent Events

  • 01 Jun 2025 According to a Bicara Therapeutics media release, company presented updated data from this study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • 22 May 2025 According to a Bicara Therapeutics media release, updated interim data from this study will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting .
  • 13 May 2025 According to a Bicara Therapeutics media release, Phase 1b expansion cohort in patients with 3L+ metastatic colorectal cancer is expected to initiate in 2025.

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