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NCT06788990 · ClinicalTrials.gov registry record · Phase 2
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Bicara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 650
- Enrollment target
- 20
- Study locations
NCT06788990: Recruiting Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Bicara Therapeutics.
NCT06788990 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Bicara Therapeutics. The registered enrollment target is 650 participants, above the 100-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (550% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06788990, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Bicara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 650 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pembrolizumab (KEYTRUDA®)
- DRUG Ficerafusp alfa
Study Locations (20)
California
- Site #0107 - La Jolla
- Site #0106 - Los Angeles
- Site#0144 - Sacramento
- Site #0130 - San Francisco
- Site #0150 - Stanford
Colorado
- Site #0122 - Aurora
- Site #0124 - Aurora
- Site#0121 - Aurora
Florida
- Site #0148 - Jacksonville
- Site #0136 - Palm Bay
- Site #0105 - Tampa
Kentucky
- Site#0109 - Lexington
- Site#0111 - Louisville
- Site#0115 - Louisville
Alabama
- Site # 0137 - Birmingham
Arizona
- Site #0147 - Phoenix
Delaware
- Site#0127 - Newark
Illinois
- Site #0133 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2025-01-28 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
What NCT06788990 shows while recruiting
NCT06788990 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (550% higher).
The record links to 2 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06788990 names 20 study sites across 10 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06788990 about?
NCT06788990 is a clinical study titled "FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC". 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, r...
What is the current status of trial NCT06788990?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 650 participants. The study started on 2025-01-28. Estimated completion is 2029-07.
What conditions does trial NCT06788990 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06788990?
The interventions under investigation include: Placebo (DRUG), Pembrolizumab (KEYTRUDA®) (DRUG), Ficerafusp alfa (DRUG).
Who is sponsoring clinical trial NCT06788990?
This trial is sponsored by Bicara Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06788990 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Head-and-neck Squamous-cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06788990's enrollment target sits among peer trials
650 1st of 24 higher than 24 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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