Ficerafusp alfa

Phase 2Small molecule

Ficerafusp alfa is one of 92 small molecule programs targeting Head and Neck Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Squamous Cell CarcinomaNot yet recruiting

Metastatic Head and Neck Squamous Cell CarcinomaRecruiting

PembrolizumabNot yet recruiting

Head and Neck Squamous Cell CarcinomaPreclinical

Not yet recruiting

Metastatic Head and Neck Squamous Cell CarcinomaPreclinical

Recruiting

PembrolizumabPhase 2

Not yet recruiting

Competition

Competitive Landscape

112 competitors in Head and Neck Squamous Cell Carcinoma

#DrugCompanyPhaseTrials

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

36 2

Erbitux

IImclone

Phase 3

27 3

Beyfortus

BeiGene

Phase 3

8 4

Imfinzi

AstraZeneca

Phase 3

6 5

Taxotere

AAvyxa

Phase 3

17 6

Ibrance

Pfizer

Phase 3

4 7

Tuoyi

CCoherus Oncology, Inc.

Phase 3

6 8

Adrucil

EElorac, Inc.

Phase 3

4 9

Gilotrif

Boehringer Ingelheim

Phase 3

4 10

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2029

Phase 2Recruiting

Metastatic Head and Neck Squamous Cell Carcinoma

NCT07807163

Q3 2029

PreclinicalRecruiting

Metastatic Head and Neck Squamous Cell Carcinoma

NCT06788990

Q2 2030

Phase 2Not yet recruiting

Pembrolizumab

NCT07465276

Q4 2030

Phase 2Recruiting

Squamous Cell Carcinoma of Head and Neck (SCCHN)

NCT07529873

Clinical

Trials by Indication[1]

Metastatic Head and Neck Squamous Cell Carcinoma2 trials

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

Recruiting·BBicara Therapeutics·Preclinical·NCT06788990·650 enrolled

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

Recruiting·BBicara Therapeutics·Phase 2·NCT07807163·160 enrolled

Pembrolizumab1 trial

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

Not yet recruiting·—·Phase 2·NCT07465276·32 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Phase I/II Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Not yet recruiting·WWashington University School of Medicine·Preclinical·NCT07552558·45 enrolled

Squamous Cell Carcinoma of Head and Neck (SCCHN)1 trial

A Phase II Study of Ficerafusp Alfa (BCA 101) in Combination With Nivolumab in Platinum Refractory Head and Neck Squamous Cell Carcinoma Patients Who Progressed Within 6 Months After Multimodal Treatment for Locally Advanced Disease ( BICARA)

Recruiting·GGroupe Oncologie Radiotherapie Tete et Cou·Phase 2·NCT07529873·131 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Ficerafusp alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ficerafusp alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ficerafusp alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bicara Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: BBicara Therapeutics

Ficerafusp alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q3 2029

Q2 2030

Q4 2030

Trials by Indication[1]

Metastatic Head and Neck Squamous Cell Carcinoma2 trials

Pembrolizumab1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Squamous Cell Carcinoma of Head and Neck (SCCHN)1 trial

References

Drug Info

Quick Facts

Related News