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Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaPhase 1/2NCT07059221

A Trial of SHR-A2102 With Adebrelimab With or Without Other Anti-tumor Therapies in Recurrent/MetastaticHead and Neck Squamous Cell Carcinoma Cancer

A Phase 1/2 study testing SHR-A2102, Adebrelimab and Cetuximab in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102/SHR-9839(sc) with Adebrelimab with or without other Antitumor Therapy in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-A2102, Adebrelimab and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
2 sitesChina
Study dates
11 Jul 2025to Mar 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • The ECOG score is 0 or 1.
  • Expected survival ≥12 weeks.
  • Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Who cannot join

  • -
  • 1. Subjects will not be screened if they meet any of the following conditions:
  • Primary tumor located in the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin;
  • 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:
Show all 13Show fewer
  • Use of any investigational drug within 4 weeks before the first dose;
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Huijie Duan contact

+86 17721286337

huijie.duan@hengrui.com

China2 sites, 2 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Lei Liu

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Ying Wang

    Recruiting

Other trials in China

About this study

Official title: 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

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102/SHR-9839(sc) 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/SHR-9839（sc） for Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Being tested
SHR-A2102, Adebrelimab, Cetuximab, SHR-9839(sc), Carboplatin / Cisplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A2102Drug

    Administration by intravenous infusion

  • AdebrelimabDrug

    Administration by intravenous infusion

  • CetuximabDrug

    Administration by intravenous infusion

  • SHR-9839(sc)Drug

    Administration by Subcutaneous injection

  • Carboplatin / CisplatinDrug

    Administration by intravenous infusion

Study groups in NCT07059221
Study groupRoleWhat they receive
SHR-A2102+AdebrelimabExperimentalNot described
Receives: Drug: SHR-A2102; Drug: Adebrelimab
SHR-A2102+Adebrelimab+CetuximabExperimentalNot described
Receives: Drug: SHR-A2102; Drug: Adebrelimab; Drug: Cetuximab
SHR-9839(sc)ExperimentalNot described
Receives: Drug: SHR-9839(sc)
Adebrelimab+ SHR-9839(sc)+ Carboplatin / CisplatinExperimentalNot described
Receives: Drug: Adebrelimab; Drug: SHR-9839(sc); Drug: Carboplatin / Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D

    RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages

    Measured: through phase IB completion, an average of 5 years

  2. Incidence and severity of AE(DLT)

    According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose

    Measured: from Day1 to 90 days after last dose

  3. ORR

    efficacy was assessed every 6 weeks as determined by RECIST1.1

    Measured: 5 years after the last subject was enrolled in the group

Secondary outcomes (4)

  1. DCR

    Since C1D1 every 6 weeks w and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 5 years after the last subject was enrolled in the group

  2. DOR

    Since C1D1 every 6 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 5 years after the last subject was enrolled in the group

  3. PFS(Investigator evaluation)

    Since C1D1 every 6 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；

    Measured: 5 years after the last subject was enrolled in the group

  4. OS(Investigator evaluation)

    Since C1D1 and death from any cause

    Measured: 5 years after the last subject was enrolled in the group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start11 Jul 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07059221
Sponsor's protocol ID
SHR-A2102-211
Status last verified
Jul 2025
First submitted
1 Jul 2025
Last updated
20 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A2102, Adebrelimab and Cetuximab in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huijie Duan (+86 17721286337, huijie.duan@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: through phase IB completion, an average of 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07059221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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