Actively Recruiting
Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC
Led by Beijing Tongren Hospital · Updated on 2026-05-04
10
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
B
Beijing Tongren Hospital
Lead Sponsor
S
Sinocelltech Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent/metastatic HNSCC patients.
CONDITIONS
Official Title
Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Have recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharyngeal, pharyngeal, or laryngeal regions
- Male or female, age 18 years or older, with ECOG performance status 0 or 1
- Experienced disease progression within 24 weeks after last PD-1 and platinum therapy or PD-1 monotherapy
- Have at least one target lesion measurable by RECIST 1.1 criteria
- Able to provide tissue for PD-L1 testing if previous PD-L1 test results are not available
- Expected to live more than 3 months
- Meet required organ function laboratory values within 7 days before enrollment, including blood counts, kidney and liver function, and coagulation parameters
You will not qualify if you...
- Suitable for local treatment instead of systemic therapy
- Have other active malignant tumors
- Have brain metastases
- Have unresolved toxicities from prior treatments worse than grade 1 (excluding chronic toxicities)
- Allergic to any known study medication ingredients
- Had major surgery, radiation (except palliative), chemotherapy, immunotherapy, or biologics within 4 weeks before enrollment
- Received tyrosine kinase inhibitors, palliative surgery, or non-specific immunomodulatory therapies within 2 weeks before enrollment
- Used immunosuppressive drugs within 4 weeks before enrollment (except short-term or physiological dose steroids)
- Have active infections requiring systemic antibiotics, active tuberculosis, positive hepatitis C or high hepatitis B viral load, or HIV infection
- Have uncontrollable pleural, abdominal, or pericardial effusions
- History of severe immune-related adverse events or myocarditis
- Serious cardiovascular or cerebrovascular diseases within 6 months, abnormal heart function, uncontrolled hypertension, or other unsuitable heart conditions
- Active autoimmune diseases
- Significant risk of bleeding
- Received live vaccines within 4 weeks before enrollment
- Pregnant or breastfeeding without contraception
- Mental illness that could affect participation
- History of organ or stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Luo Zhang
CONTACT
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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