Ficerafusp alfa

Shows activity

Also known as:

BCA101 FMAB2

Cancer types include:

cervical cancer colon cancer head and neck cancer ovarian cancer pancreas cancer

TrialFetch AI Analysis

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Overview

Ficerafusp alfa (BCA101; FMAB2) is an investigational intravenous cancer therapy studied alone and with pembrolizumab. Human results are available, but the reported efficacy findings are preliminary and come from early-phase, single-arm cohorts rather than a randomized comparison. (pmc.ncbi.nlm.nih.gov)

Mechanism of action

Ficerafusp alfa combines an antibody against EGFR with a portion of the TGF-β receptor that acts as a TGF-β “trap.” The design aims to inhibit EGFR signaling while neutralizing TGF-β in the tumor environment. In a phase I study, weekly doses of at least 500 mg produced prolonged neutralization of TGF-β1 in plasma. (pubmed.ncbi.nlm.nih.gov)

Efficacy

In a first-line phase I/Ib cohort for PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma, 42 patients received ficerafusp alfa 1,500 mg weekly plus pembrolizumab; 39 were evaluable for response. The confirmed response rate was 54% (15/28) in patients with HPV-negative tumors, including 21% complete responses, and 27% (3/11) in those with HPV-positive tumors. In the HPV-negative group, median response duration was 21.7 months and median progression-free survival was 9.9 months. (ascopubs.org)

A separate conference abstract reported a 57% response rate (17/30 evaluable patients) with a lower, 750-mg weekly dose plus pembrolizumab in HPV-negative disease. In an earlier dose-escalation study across advanced solid tumors, responses occurred in 1/42 evaluable patients receiving ficerafusp alfa alone and 4/13 receiving it with pembrolizumab. These cohorts do not establish how much benefit ficerafusp alfa adds to pembrolizumab. (annalsofoncology.org)

Safety

In the 1,500-mg head-and-neck cohort, 19/42 patients (45%) had a grade 3 treatment-related adverse event and one (2%) had a grade 4 event; none was fatal. The most common grade 3 or higher events were anemia (14%) and acneiform dermatitis (12%). Treatment-related events led to discontinuation of ficerafusp alfa in 5/42 patients (12%). (ascopubs.org)

Active trials using Ficerafusp alfa

Found 3 active trials using this drug:

A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Sponsor: Bicara Therapeutics (industry) Phase: 2 Start date: Sept. 8, 2026

TrialFetch AI summary: Adults with previously untreated, PD-L1–positive (CPS ≥1) recurrent or metastatic HNSCC, including HPV-negative oropharyngeal cancer, receive ficerafusp alfa plus pembrolizumab. After 12 weeks of weekly ficerafusp alfa, patients without progression are randomized to every-3-week or continued weekly ficerafusp alfa maintenance; ficerafusp alfa targets EGFR and traps TGF-β.

ClinicalTrials.gov ID: NCT07807163

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Sponsor: Bicara Therapeutics (industry) Phase: 2/3 Start date: Jan. 28, 2025

TrialFetch AI summary: Adults with PD-L1–positive (CPS ≥1), recurrent or metastatic HNSCC and no prior systemic therapy for recurrent/metastatic disease receive first-line pembrolizumab plus ficerafusp alfa or placebo. Ficerafusp alfa is an investigational agent that blocks EGFR and traps TGF-β.

ClinicalTrials.gov ID: NCT06788990

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

Sponsor: Bicara Therapeutics (industry) Phase: 1 Start date: June 1, 2020

TrialFetch AI summary: Adults with advanced EGFR-driven solid tumors, including selected head and neck, anal, cutaneous, lung, and colorectal cancers, receive intravenous BCA101 alone or with pembrolizumab, depending on the cohort. BCA101 is a bifunctional anti-EGFR antibody fused to a TGF-β receptor domain that inhibits EGFR signaling and traps TGF-β.

ClinicalTrials.gov ID: NCT04429542