Actively Recruiting
A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-09-10
50
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
Sponsors
T
Taipei Veterans General Hospital, Taiwan
Lead Sponsor
F
FBD Biologics Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-randomized, open-label, dose-escalation and dose-expansion phase I/II clinical study to evaluate the safety, tolerability, and efficacy of HCB101 in combination with pembrolizumab in patients with platinum-refractory recurrent/metastatic HNSCC. The trial consists of two phases: the dose-escalation phase (I) and the dose-expansion phase (II). Subjects will receive a weekly single dose of HCB101 IV infusion over 60 (±10) minutes on Days 1, 8, and 15 in each 21-day cycle in combination with pembrolizumab (200 mg IV day 1; given every 21 days) until unacceptable AE(s), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study whichever occurs first.
CONDITIONS
Official Title
A Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects able to understand and willing to provide signed informed consent
- Male and female subjects aged 18 years or older at consent
- Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC)
- Disease progression after first cisplatin-based therapy for recurrent or metastatic HNSCC or within 6 months after cisplatin-based chemoradiotherapy
- At least one measurable lesion as per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
- Life expectancy of 12 weeks or more
- Adequate organ function meeting specified laboratory criteria
- Women of childbearing potential must have a negative serum pregnancy test during screening
You will not qualify if you...
- Known hypersensitivity to any study intervention components
- Other malignancies requiring treatment within 2 years prior to first dose except certain treated skin cancers
- Primary tumor in central nervous system or active/untreated CNS metastases or carcinomatous meningitis
- Significant cardiovascular conditions including unstable or recent heart issues
- Abnormal ECG deemed clinically meaningful by investigator
- Unresolved prior treatment toxicities above Grade 1 except alopecia and anemia
- Known bleeding disorders or recent hemolytic anemia or Evans Syndrome
- Active autoimmune diseases requiring systemic treatment within past 2 years
- History or current non-infectious pneumonitis
- Severe hypersensitivity to monoclonal antibodies
- Major surgery or radical radiotherapy within 28 days prior to first dose
- Recent systemic cancer therapy or herbal medications within specified timeframes before first dose
- Current use of vitamin K antagonist anticoagulants like warfarin
- Previous treatment targeting CD47 or SIRPα pathway
- Previous pembrolizumab treatment
- Live vaccine within 30 days prior to pembrolizumab administration
- Immunodeficiency or recent immunosuppressive therapy within 7 days prior to pembrolizumab
- Participation in other investigational product studies within specified recent timeframes
- Women of reproductive potential unable to use effective contraception during and 4 months after treatment
- Women breastfeeding during and 4 months after treatment
- Uncontrolled or active infections including HIV, tuberculosis, hepatitis B or C
- Other medical, psychiatric, or social conditions interfering with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chang-Gung Memorial Hospital(Lin-Kou)
Taoyuan, Guishan District, Taiwan, 333
Actively Recruiting
2
National Taiwan University Hospital
Taipei, Taipei city, Taiwan, 100
Actively Recruiting
3
Taipei Veterans General Hospital
Taipei, taipei city, Taiwan, 112
Actively Recruiting
Research Team
I
Iris chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here