Actively Recruiting
A Phase I/II Trial of HCB101 Combined With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-09-10
50
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the safety, tolerability, and effectiveness of a new drug called HCB101 combined with pembrolizumab in patients with head and neck squamous cell carcinoma (HNSCC) that has returned or spread after platinum-based chemotherapy. This study includes two parts: a dose-escalation phase to find the best dose, and a dose-expansion phase to further assess the treatment. It focuses on patients whose cancer progressed after initial cisplatin therapy or within six months after chemoradiation. Participants will receive weekly intravenous infusions of HCB101 on Days 1, 8, and 15 of each 21-day cycle. Pembrolizumab will also be given intravenously at 200 mg on Day 1 of each 21-day cycle. Treatment continues until unacceptable side effects, disease progression, withdrawal, or other reasons for stopping the study. This approach allows close monitoring of how well the combination is tolerated and how it affects the cancer. Throughout the study, participants will undergo regular assessments including scans to measure tumor response, laboratory tests to check organ function, and questionnaires on quality of life. Researchers will track adverse events and measure outcomes like overall response rate and progression-free survival over two years. The study aims to find the highest dose patients can tolerate and evaluate how the combination therapy impacts the disease and patient well-being.
CONDITIONS
Brief 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...
- Able to understand and willing to provide signed informed consent.
- Male or female aged 18 years or older at consent.
- Histologically or cytologically confirmed diagnosis of head and neck squamous cell carcinoma.
- Disease progressed after first cisplatin-based therapy or within 6 months after cisplatin-based chemoradiotherapy.
- At least one measurable lesion by RECIST v1.1.
- ECOG performance status of 0 to 2 at screening.
- Life expectancy of at least 12 weeks.
- Adequate organ function based on lab tests, including neutrophils, platelets, hemoglobin, liver enzymes, creatinine clearance, and coagulation.
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to first dose.
You will not qualify if you...
- Known allergy to any components of the study drugs.
- Other malignancies needing treatment within 2 years, except certain skin cancers treated without relapse.
- Primary central nervous system tumor, active or untreated brain metastases, or carcinomatous meningitis.
- Significant cardiovascular conditions, including unstable heart issues or abnormal ECG.
- Unresolved treatment-related toxicities above Grade 1 except for alopecia and anemia.
- Known bleeding disorders or recent hemolytic anemia.
- Active autoimmune diseases needing systemic treatment within 2 years.
- History of non-infectious pneumonitis or severe hypersensitivity to monoclonal antibodies.
- Recent major surgery or radical radiotherapy within 28 days.
- Recent systemic cancer therapies or herbal medications within specified periods.
- Active use of vitamin K antagonist anticoagulants like warfarin.
- Previous treatment targeting CD47 or SIRPα pathway or prior pembrolizumab treatment.
- Live vaccine within 30 days before pembrolizumab.
- Immunodeficiency or recent immunosuppressive therapy.
- Participation in another investigational study within 14 days or appropriate half-lives.
- Women unable to use effective contraception or breastfeeding during treatment and 4 months after.
- Uncontrolled or active infections including HIV, tuberculosis, hepatitis B or C.
- Any medical, psychiatric, or social condition that may affect safety or study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive HCB101 weekly and pembrolizumab 200 mg intravenously every 21 days.
Weekly visits and visits every 3 weeks for treatment administration
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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