SHR-A2102 with adebrelimab, with or without other anti-cancer drugs, for recurrent or metastatic head and neck squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional study explores dosing, safety, tolerability, and preliminary efficacy of SHR-A2102 given with the immune agent adebrelimab, either alone or combined with other anti-tumor therapies such as cetuximab, in patients with recurrent or metastatic head and neck squamous cell carcinoma. The phase 1 portion uses dose-escalation to identify a recommended dose and characterize safety, while phase 2 enrolls expansion cohorts to gather preliminary activity data. Eligible participants must have histologically confirmed squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx, at least one measurable lesion by RECIST v1.1, ECOG 0–1, adequate organ function, and available tumor tissue. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals and is being conducted at cancer centers in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.
2. Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
3. At least one measurable lesion according to RECIST v1.1 criteria.
4. The ECOG score is 0 or 1.
5. Expected survival ≥12 weeks.
6. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Exclusion Criteria:

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1\. Subjects will not be screened if they meet any of the following conditions:

1. Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
2. Locally advanced patients who are candidates for curative surgery or local therapy and have the intention to undergo such treatment;

2\. Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.

3\. Prior treatments or medications before the first dose of the study drug:

1. Use of any investigational drug within 4 weeks before the first dose;
2. Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) study or follow-up in an interventional study; 4. Active autoimmune disease or a history of autoimmune disorders. 5. Residual toxicity from prior anticancer therapy not resolved to ≤Grade 1 (CTCAE v5.0) (except for non-safety risks, such as alopecia) or not meeting the inclusion/exclusion criteria.

6\. Uncontrolled or symptomatic active CNS metastases. 7. Symptomatic visceral metastases with imminent life-threatening complications .

8\. Severe bone damage caused by tumor bone metastasis, including severe bone pain that is poorly controlled; pathological fractures in important areas that occurred within 6 months before the first medication or are expected to occur very soon; and spinal cord compression.

9\. Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions.

10\. Other active malignancies within 3 years before study entry. 11. Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.

12\. Clinically significant cardiovascular disease. 13. Active or chronic infections of clinical significance. 14. Pregnancy or lactation. 15. Other factors that, in the investigator's judgment, may lead to premature study discontinuation.

Where it's running

• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Huijie Duan
• Email: huijie.duan@hengrui.com
• Phone: +86 17721286337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

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• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

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  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.