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

Part of paid clinical trials in Tyler, Texas.

Sponsor
Bicara Therapeutics
Study ID
NCT07807163
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ficerafusp alfa — DRUG
    investigational agent
  • Pembrolizumab (KEYTRUDA®) — DRUG
    immunotherapy agent used in combination with investigational agent

Study Details

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).

Key Dates

First listed
Sep 8, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    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.
  • Experimental: Arm B
    Continuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Site US074TylerTexas75702-

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