Recruiting

Phase 2

Phase 3

Ficerafusp Alfa & PembrolizumabFORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Sponsor:

Bicara Therapeutics

Code:

NCT06788990

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ficerafusp alfa

Pembrolizumab (KEYTRUDA®)

Placebo

Study Details

Brief summary:

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).

This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Study ID

NCT06788990

Start date

Jan 28, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study Design

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 2 Arm A

ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)

experimental: Phase 2 Arm B

ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W

placebo comparator: Phase 2 Arm C

placebo QW + pembrolizumab 200 mg Q3W

experimental: Phase 3 OBD Arm

ficerafusp alfa OBD + pembrolizumab 200 mg Q3W

placebo comparator: Phase 3 Arm C

placebo QW + pembrolizumab 200 mg Q3W

Interventions

Ficerafusp alfa

Investigational

Pembrolizumab (KEYTRUDA®)

Immunotherapy agent used in combination with investigational agent

Placebo

Placebo Control

Primary outcome measure

Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation. [ Time Frame: Up to 30 days post end of treatment for TEAEs (90 days for SAEs). ]
Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) [ Time Frame: Approximately 1 year. ]
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR. [ Time Frame: Approximately 2 years. ]
Phase 3 - Overall Survival (OS) [ Time Frame: Approximately 3 years. ]

Central Contacts and Locations

Central contacts

Medical Affairs

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

Locations

Site # 0137

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0147

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0107

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0106

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0144

Recruiting

Sacramento, California, United States, 95817

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0130

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0150

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0122

Recruiting

Aurora, Colorado, United States, 80012

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0124

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0121

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0148

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0136

Recruiting

Palm Bay, Florida, United States, 32901

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0105

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0140

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0149

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0111

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0115

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0112

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0131

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0101

Recruiting

Boston, Massachusetts, United States, 02136

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0156

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0146

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0114

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0145

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0155

Recruiting

New York, New York, United States, 10003

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0142

Recruiting

New York, New York, United States, 10021

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0118

Recruiting

Durham, North Carolina, United States, 27703

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0154

Recruiting

Canton, Ohio, United States, 44708

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0117

Recruiting

Cincinnati, Ohio, United States, 45221

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0151

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0108

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0113

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0103

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0123

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0132

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0104

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0126

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0116

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0102

Recruiting

Houston, Texas, United States, 77005

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0152

Recruiting

Waco, Texas, United States, 676712

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0134

Recruiting

Charlottesville, Virginia, United States, 22904

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0129

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0138

Recruiting

Richmond, Virginia, United States, 23249

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site # 0160

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site # 0159

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0125

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site#0120

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0141

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0157

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site # 0153

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0202

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site #0203

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

Site # 0204

Recruiting

Toronto, Canada, M4N 3M5

Contacts

Principal Investigator

617-468-4219 FORTIFI_inquiries@bicara.com

More Information

Sponsor

Bicara Therapeutics

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

Phase 2/3
Ficerafusp alfa
BCA101
Recurrent Head and Neck Squamous Cell Carcinoma (R HNSCC)
Metastatic Head and Neck Squamous Cell Carcinoma (M HNSCC)
Pembrolizumab
EGFR
TGF-beta
HNSCC
PD-L1+
Head and Neck cancer
Oral Cavity
Oropharynx
Larynx
Hypopharynx

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Bicara Therapeutics on 2026-07-17.