New drug cocktail aims to tackle recurrent head and neck cancer
NCT ID NCT07059221
First seen Jun 30, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This study tests a combination of two investigational drugs, SHR-A2102 and adebrelimab, with or without other anti-cancer therapies, in people whose head and neck squamous cell carcinoma has returned or spread. The goal is to find safe and effective doses and see if the combination can shrink tumors. Participants must have measurable disease and be in generally good health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-A2102 and adebrelimab (with or without cetuximab, SHR-9839, or carboplatin/cisplatin)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with head and neck cancer that has returned or spread.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so the benefits and risks are not yet fully known. Side effects from the drug combinations may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: \- 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, 400030, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug combo targets Hard-to-Treat head and neck cancers
- Promising drug cocktail targets Hard-to-Treat head and neck cancer
- New drug combo targets Hard-to-Treat head and neck cancer
- New hope for head and neck cancer: drug combo shows promise after standard treatment fails
- Promising combo therapy for head and neck cancer hits early snag
- Gut health boost may tame immunotherapy side effects in head and neck cancer