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

A Multicenter, Open-label Phase Ib/II Clinical Trial of SHR-A2102 Injection in Combination With Adebrelimab Injection, With or Without Other Anti-tumor Therapies, in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

This tests whether SHR-A2102 combined with adebrelimab, with or without other anti-cancer therapies, is safe and helps adults with recurrent or metastatic head and neck squamous cell carcinoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 2 sites (Chongqing, Chongqing Municipality and 1 other locations)
• Trial ID: NCT07059221 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with recurrent or metastatic squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx who have measurable disease, ECOG 0–1, adequate organ function, and available tumor tissue are the intended participants.

Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, primary tumors outside the specified head and neck sites, or who cannot comply with contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this combination could provide a new treatment option that improves tumor control or survival for patients with recurrent or metastatic head and neck squamous cell carcinoma.

How similar studies have performed: Immune checkpoint inhibitors have produced benefits in recurrent/metastatic head and neck cancer and combinations with targeted agents like cetuximab have been explored, but combination regimens remain investigational with mixed results to date.

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:

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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;
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.

Where this trial is running

Chongqing, Chongqing Municipality and 1 other locations

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

Study contacts

• Study coordinator: Yifan Shen

Conditions Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma