NCT07807163

Brief Summary

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
29mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2029

First Submitted

Initial submission to the registry

August 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

August 18, 2026

Last Update Submit

September 3, 2026

Conditions

Metastatic Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell Carcinoma

Keywords

head and neck cancerHNSCCrecurrent HNSCCmetastatic HNSCCfirst line treatmentPhase 2Recurrent Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaPembrolizumabPD-L1+TGF-betaoral cavityoropharynxlarynxhypopharynxFicerafusp alfaSCCHNHPVnegHPV negativeHPV-BCA101

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants in maintenance phase who are progression-free as assessed by blinded independent central review (BICR) per RECIST 1.1 and alive.

    Approximately 9 months.

Secondary Outcomes (13)

  • Serum exposure of ficerafusp alfa.

    Approximately 9 months.

  • Objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR).

    Approximately 1 year.

  • Disease control rate (DCR) per RECIST 1.1 by blinded independent central review (BICR)

    Approximately 1 year.

  • Clinical Benefit Rate (CBR) per RECIST 1.1 by blinded independent central review (BICR)

    Approximately 3 years.

  • Duration of Response (DOR) per RECIST 1.1 by blinded independent central review (BICR).

    Approximately 3 years.

  • +8 more secondary outcomes

Study Arms (2)

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.

Drug: Ficerafusp alfaDrug: Pembrolizumab (KEYTRUDA®)

Arm B

EXPERIMENTAL

Continuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.

Drug: Ficerafusp alfaDrug: Pembrolizumab (KEYTRUDA®)

Interventions

Ficerafusp alfaDRUG

investigational agent

Arm AArm B
Pembrolizumab (KEYTRUDA®)DRUG

immunotherapy agent used in combination with investigational agent

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years on the day the Informed Consent Form is signed.
  • Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
  • No prior systemic therapy administered in the R or M setting; and completed systemic therapy \>6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.
  • Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.
  • PD-L1 CPS ≥1.
  • Measurable disease based on RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function, as defined in the protocol.

You may not qualify if:

  • Disease suitable for local therapy administered with curative intent.
  • Prior treatment with anti-TGFβ therapy.
  • Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
  • Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
  • Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
  • Progressive disease \<6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
  • Life expectancy less than 3 months.
  • Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
  • Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
  • Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
  • Active autoimmune disease requiring systemic treatment in the past 2 years.
  • Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
  • Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
  • Known history of human immunodeficiency virus (HIV).
  • Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site US074

Tyler, Texas, 75702, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCamurati-Engelmann SyndromeLaryngeal Diseases

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Medical Affairs

CONTACT

1-617-468-4219FORTIFI_inquiries@bicara.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2026

First Posted

September 8, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations

US(1)