Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BCA101, FmAb2
Ficerafusp alfa · 6 trials · 17 indications
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.
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.
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.
The maximum tolerated dose (MTD) is defined as the highest dose level at which 0 or 1 patients of a cohort experience dose-limiting toxicity during the dose limiting toxicity (DLT) window. DLTs are defined in the protocol.
Response will be defined according to the systematic pTR system. pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor). pCR is defined as follows: 100% of sample characterized by tumor necrosis, keratinous debris, and/or giant cells/histiocytes
Incidence and severity of AEs and SAEs
Incidence and severity of AEs and SAEs
Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Arm A | EXPERIMENTAL | Loading phase (12 weeks): Ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W. Maintenance phase: Ficerafusp alfa 2250 mg Q3W (alternative dose) + pembrolizumab 200 mg Q3W. |
| Arm B | EXPERIMENTAL | Continuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W. |
| 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 |
| Phase 1 Dose Level 1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa | EXPERIMENTAL | Treatment during the Phase 1 Level 1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 2 doses of neoadjuvant pembrolizumab at 200 mg (given on D1 and D22), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. |
| Phase 1 Dose Level -1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa | EXPERIMENTAL | Treatment during the Phase 1 Level -1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. |
| Phase 1 Dose Level -2: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa | EXPERIMENTAL | Treatment during the Phase 1 Level -2 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1 and 4), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. |
| Phase 1 Dose Level -3: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa | EXPERIMENTAL | Treatment during the Phase 1 Level -3 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Day 1), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. |
| Phase 2: Maximum Tolerable Dose (MTD) Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa | EXPERIMENTAL | Treatment consists of SBRT beginning on D1 at the dose and number of fractions established in phase I, neoadjuvant pembrolizumab 200 mg at the number of doses established in phase I, and 4 weekly doses of ficerafusp alfa 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. |
| BCA101 Monotherapy | EXPERIMENTAL | Route: IV Infusion Frequency: QW Current Dose: 1500mg |
| BCA101 + pembrolizumab | EXPERIMENTAL | Route: IV Infusion Frequency: Q3W Dose: 200mg |
| Name | Type | Description |
|---|---|---|
| Ficerafusp alfa | DRUG | Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol. |
| Pembrolizumab | DRUG | Monoclonal antibody, single-dose vial, via intravenous infusion per protocol. |
| 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 (KEYTRUDA®) | DRUG | immunotherapy agent used in combination with investigational agent |
| Placebo | DRUG | Placebo Control |
| Hypofractionated Stereotactic Body Radiotherapy (SBRT) | RADIATION | 1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II |
| BCA101 | DRUG | EGFR/TGFβ fusion monoclonal antibody |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SC...
Ficerafusp alfa is an investigational oncology therapy being studied in head and neck squamous cell carcinoma, including recurrent, metastatic, and platinum-refractory disease. Research includes first-line recurrent or metastatic HNSCC, HPV-negative squamous cell carcinoma, and resectable disease in the neoadjuvant setting. It is not approved for any indication.
Ficerafusp alfa targets EGFR and TGF-beta. It is designed to act on both pathways, combining EGFR inhibition with TGF-beta blockade in a single agent. This dual-target approach is being evaluated in squamous cell carcinoma of the head and neck, where EGFR signaling is a recognized driver of tumor growth.
Ficerafusp alfa is being developed by Bicara Therapeutics Inc., which trades under the ticker BCAX. The company holds the asset, also known as BCA101, and is running the clinical program across multiple head and neck cancer studies, including combinations with pembrolizumab, nivolumab, and stereotactic body radiotherapy.
Ficerafusp alfa is in Phase 1 and Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program has received Breakthrough Therapy designation, and the trials span first-line recurrent or metastatic disease, platinum-refractory disease, and neoadjuvant treatment of resectable squamous cell carcinoma.
Ficerafusp alfa is being studied in NCT07807163, a Phase 2 trial of weekly ficerafusp alfa plus pembrolizumab versus alternative dosing in first-line recurrent or metastatic HNSCC; NCT07552558, a Phase 1 trial with pembrolizumab and stereotactic body radiotherapy; NCT07529873, a Phase 2 trial with nivolumab in platinum-refractory HNSCC; and NCT07465276, a Phase 2 neoadjuvant trial with pembrolizumab.
Yes, ficerafusp alfa is also known as BCA101. BCA101 is the earlier code name for the same investigational compound developed by Bicara Therapeutics Inc. under ticker BCAX. Searches for either name refer to the same EGFR and TGF-beta targeting agent being studied in head and neck squamous cell carcinoma.