Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ficerafusp alfa · 3 trials · 5 indications
the objective response rate (ORR) which is defined as the proportion of patients with a confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by the investigator according to RECIST criteria 1.1.
pTR-2 rate is defined as ≥50% pathological response of the primary tumor using the surgical specimen following neoadjuvant therapy as established by 2 independent pathologists.
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
OS: Defined as the time from the randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Ficerafusp + nivolumab | EXPERIMENTAL | Combination of Ficerafusp alfa + Nivolumab * Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks |
| Nivolumab | ACTIVE_COMPARATOR | Nivolumab monotherapy • Nivolumab 240 mg every 2 weeks |
| Ficerafusp Alfa plus Pembrolizumab | EXPERIMENTAL | 32 participants will be enrolled and will complete: * Baseline visit * Cycle 1 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Days 1, 8, and 15: predetermined dose of Ficerafusp Alfa 1x daily. * Cycle 2 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Day 1: predetermined dose of Ficerafusp Alfa 1x daily. * Standard of care surgery * End of treatment visit * Follow up for up to 2 years |
| Phase 2 Arm A | EXPERIMENTAL | ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W) |
| Phase 2 Arm B | EXPERIMENTAL | ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W |
| Phase 2 Arm C | PLACEBO_COMPARATOR | placebo QW + pembrolizumab 200 mg Q3W |
| Phase 3 OBD Arm | EXPERIMENTAL | ficerafusp alfa OBD + pembrolizumab 200 mg Q3W |
| Phase 3 Arm C | PLACEBO_COMPARATOR | placebo QW + pembrolizumab 200 mg Q3W |
| Name | Type | Description |
|---|---|---|
| Ficerafusp alfa | DRUG | Ficerafusp alfais a bifunctional recombinant fusion protein consisting of a chimeric anti-EGFR mAb and human TGFβRII-ECD |
| Nivolumab | DRUG | Nivolumab is a monoclonal antibody that binds to and blocks the programmed cell death 1 receptor. It is used to treat certain cancers. |
| Pembrolizumab | DRUG | Monoclonal antibody, single-dose vial, via intravenous infusion per protocol. |
| Pembrolizumab (KEYTRUDA®) | DRUG | Immunotherapy agent used in combination with investigational agent |
| Placebo | DRUG | Placebo Control |
Inclusion Criteria: * Patient or legally authorized representative, if applicable, has signed and dated informed consent form (ICF) indicating that the patient (or legally authorized representative, if applicable) has been informed of all the pertinent aspects of the study prior to enrollment and t...
Ficerafusp alfa is an investigational oncology therapy being studied for the treatment of head and neck squamous cell carcinoma (HNSCC), including metastatic and recurrent forms of the disease. It is being evaluated in combination with other agents such as pembrolizumab and nivolumab across multiple clinical trials.
Ficerafusp alfa is being developed by Bicara Therapeutics Inc., a biopharmaceutical company traded under the ticker symbol BCAX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with head and neck squamous cell carcinoma.
Ficerafusp alfa is currently in Phase 2 clinical development. It has not been approved by regulatory authorities and remains an investigational agent. The drug has received Breakthrough Therapy designation from the FDA, which is intended to expedite its development and review process.
Ficerafusp alfa is being studied in several Phase 2 trials. NCT06788990 (FORTIFI-HN01) evaluates it with pembrolizumab in first-line PD-L1-positive recurrent or metastatic HNSCC. NCT07465276 tests it as neoadjuvant therapy with pembrolizumab in resectable squamous cell carcinoma. NCT07529873 studies it with nivolumab in platinum-refractory HNSCC.
Yes, Ficerafusp alfa is also known as BCA101. The clinical trial NCT06788990, titled FORTIFI-HN01, refers to the drug as Ficerafusp Alfa (BCA101), confirming that both names refer to the same investigational therapy being developed by Bicara Therapeutics.
FORTIFI-HN01 (NCT06788990) is a Phase 2, randomized, placebo-controlled study of Ficerafusp alfa in combination with pembrolizumab for first-line treatment of PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. The trial is recruiting approximately 650 participants across multiple countries including the United States and European nations.