NCT07059221 A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer
| NCT ID | NCT07059221 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2025-07-11 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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. The age of signing the informed consent is \>= 18 years, regardless of gender. 3. Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology. 4. Tumors with primary foci located in the oropharynx, oral cavity, hypopharynx and larynx. 5. Provide archived or fresh tumor tissue for test. 6. At least one measurable lesion according to RECIST v1.1 criteria. 7. The ECOG score is 0 or 1. 8. Expected survival ≥12 weeks. 9. Good level of organ function. 10. 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: \- 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; 3. Presence of necrotic lesions or significant tumor invasion into adjacent organs or blood vessels, as assessed by the investigator, posing a high risk of major bleeding. 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; 3. Last dose of anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, targeted therapy, etc.) within 4 weeksbefore the first dose; for small-molecule targeted drugs, within 2 weeks or 5 half-lives (whichever is longer); traditional Chinese medicine with antitumor indications within 2 weeks before the first dose. 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、 Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions. 9、 Other active malignancies within 3 years before study entry. 10、 Clinically significant cardiovascular disease. 11、 Active or chronic infections of clinical significance. 12、 Pregnancy or lactation. 13、 Other factors that, in the investigator's judgment, may lead to premature study discontinuation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07059221 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07059221 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07059221 currently recruiting?
Yes, NCT07059221 is actively recruiting participants. Contact the research team at yifan.shen.ys18@hengrui.com for enrollment information.
Where is the NCT07059221 trial being conducted?
This trial is being conducted at Chongqing, China, Chengdu, China.
Who is sponsoring the NCT07059221 clinical trial?
NCT07059221 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 96 participants.