Actively Recruiting
A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-07-22
96
Participants Needed
2
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. To explore the reasonable dosage of SHR-A2102 for n Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
CONDITIONS
Official Title
A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to give informed consent and comply with study procedures
- Age 18 years or older, any gender
- Confirmed advanced or distant metastatic head and neck squamous cell carcinoma by histology or cytology
- Primary tumor located in the oropharynx, oral cavity, hypopharynx, or larynx
- Provide archived or fresh tumor tissue for testing
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Good organ function
- Use of highly effective contraception for males with partners of childbearing potential and for fertile females
You will not qualify if you...
- Primary tumor located in nasopharynx, salivary glands, sinuses, skin, or unknown primary origin
- Candidates for curative surgery or local therapy with intention to undergo such treatment
- Necrotic lesions or significant tumor invasion posing high risk of major bleeding
- Known hypersensitivity to the study drug or severe allergic reactions to monoclonal antibodies
- Use of any investigational drug within 4 weeks before first dose
- Concurrent enrollment in another clinical trial except observational or follow-up studies
- Recent anticancer therapy within specified washout periods
- Active autoimmune disease or history of autoimmune disorders
- Unresolved toxicity from prior anticancer therapy greater than Grade 1 (except alopecia)
- Uncontrolled or symptomatic active CNS metastases
- Symptomatic visceral metastases with imminent life-threatening complications
- Known or suspected interstitial lung disease or severe lung conditions
- Other active malignancies within 3 years
- Clinically significant cardiovascular disease
- Active or chronic infections of clinical significance
- Pregnancy or lactation
- Other factors that may lead to early study discontinuation per investigator's judgment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yifan Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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