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Metastatic Head and Neck Squamous Cell CarcinomaPhase 2FORTIFI-FLEXNCT07807163

A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC

A Phase 2 study testing Ficerafusp alfa and Pembrolizumab (KEYTRUDA®) in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Bicara Therapeutics at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ficerafusp alfa and Pembrolizumab (KEYTRUDA®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
7 sitesUnited States
Study dates
Sep 2026to Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
  • Use of a live or live attenuated vaccine within 4 weeks prior to Screening.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical Affairs contact

1-617-468-4219

FORTIFI_inquiries@bicara.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Site US069

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Site US077

    Fort Myers, Florida, 33980

    Recruiting

  • Site US078

    Orlando, Florida, 32827

    Recruiting

  • Site US073

    Roanoke, Virginia, 24014

    Recruiting

  • Site US075

    St. Petersburg, Florida, 33701

    Recruiting

  • Site US074

    Tyler, Texas, 75702

    Recruiting

  • Site US076

    West Palm Beach, Florida, 33410

    Recruiting

Other trials in United States

About this study

Official title: 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

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).

Read the detailed description

The mechanism of action of ficerafusp alfa involves dual targeting of two cancer targets, EGFR and TGF-β, which are known to drive solid tumor growth and metastasis.

All participants will receive ficerafusp alfa 1500 mg once weekly (QW in combination with pembrolizumab 200 mg every three weeks (Q3W) for 12 weeks (loading phase). Participants who remain on study without progression at the end of the loading phase will enter the maintenance phase and will be randomized 2:1 to one of the following arms:

Arm A: Ficerafusp alfa 2250 mg Q3W [alternative dose] + pembrolizumab 200 mg Q3W Arm B: Ficerafusp alfa 1500 mg QW [standard dose] + pembrolizumab 200 mg Q3W.

Being tested
Ficerafusp alfa, Pembrolizumab (KEYTRUDA®)
Keywords
head and neck cancer, HNSCC, recurrent HNSCC, metastatic HNSCC, first line treatment, Phase 2, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Pembrolizumab, PD-L1+, TGF-beta, oral cavity, oropharynx, larynx, hypopharynx, Ficerafusp alfa, SCCHN, HPVneg, HPV negative, HPV-
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Camurati-Engelmann Syndrome, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ficerafusp alfaDrug

    investigational agent

  • Pembrolizumab (KEYTRUDA®)Drug

    immunotherapy agent used in combination with investigational agent

Study groups in NCT07807163
Study groupRoleWhat they receive
Arm AExperimentalLoading 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.
Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab (KEYTRUDA®)
Arm BExperimentalContinuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.
Receives: Drug: Ficerafusp alfa; Drug: Pembrolizumab (KEYTRUDA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 9 months.

Secondary outcomes (13)

  1. Serum exposure of ficerafusp alfa.

    Pre- and post-infusion serum concentrations and area under the curve (AUC) for ficerafusp alfa.

    Measured: Approximately 9 months.

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

    ORR is defined as the proportion of subjects who have a confirmed CR or PR per RECIST 1.1. by BICR.

    Measured: Approximately 1 year.

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

    DCR is defined as the proportion of subjects who have a SD, CR or PR per RECIST 1.1. by BICR

    Measured: Approximately 1 year.

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

    CBR is defined as the proportion of subjects who demonstrated CR + PR + SD>6 months per RECIST 1.1 by BICR.

    Measured: Approximately 3 years.

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

    For subjects who demonstrated CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first per RECIST 1.1 by BICR.

    Measured: Approximately 3 years.

  6. Progression-free survival (PFS) per RECIST 1.1 by blinded independent central review (BICR).

    Defined as the time from Cycle 1 Day 1[TK16.1] to the first documented PD per RECIST 1.1 as determined by BICR or death due to any cause, whichever occurs first.

    Measured: Approximately 3 years.

  7. Overall Survival (OS)

    Defined as the time from the Cycle 1 Day 1 to death due to any cause.

    Measured: Approximately 3 years.

  8. Time to Response (TTR) per RECIST 1.1 by blinded independent central review (BICR)

    For subjects who demonstrated CR or PR, TTR is defined as the time from Cycle 1 Day 1 to first documented evidence of CR or PR per RECIST 1.1 by BICR.

    Measured: Approximately 3 years.

  9. Deep Response Rate by blinded independent central review (BICR)

    Defined as the proportion of responders who achieve a deep response.

    Measured: Approximately 3 years.

  10. Time to maximum tumor shrinkage

    Time to maximum tumor shrinkage is defined as the time from Cycle 1 Day 1 to the maximum reduction in target lesion diameter by BICR.

    Measured: Approximately 3 years.

  11. Incidence of ≥Grade 3 TEAEs

    Measured: Up to 30 days post end of treatment.

  12. Incidence of Serious adverse events (SAEs)

    Measured: Up to 90 days post end of treatment.

  13. Incidence of Adverse events (AEs) leading to dose modifications (dose reduction, interruption, dose held, or discontinuation)

    Measured: Up to 90 days post end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807163
Sponsor's protocol ID
BCA101X201
Other IDs
2026-526741-10-00
Acronym
FORTIFI-FLEX
Status last verified
Oct 2026
First submitted
18 Aug 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ficerafusp alfa and Pembrolizumab (KEYTRUDA®) in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Bicara Therapeutics at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Affairs (1-617-468-4219, FORTIFI_inquiries@bicara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants in maintenance phase who are progression-free as assessed by blinded independent central review (BICR) per RECIST 1.1 and alive. (time frame: Approximately 9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07807163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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