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NCT Number: NCT07059221

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

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

  • 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;
  • Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.
  • Prior treatments or medications before the first dose of the study drug:
  • 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.
  • Uncontrolled or symptomatic active CNS metastases. 7. Symptomatic visceral metastases with imminent life-threatening complications .
  • 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.
  • Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions.
  • 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.
  • 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.

Treatment and study plan

SHR-A2102

Drug

Administration by intravenous infusion

Adebrelimab

Drug

Administration by intravenous infusion

Cetuximab

Drug

Administration by intravenous infusion

SHR-9839(sc)

Drug

Administration by Subcutaneous injection

Carboplatin / Cisplatin

Drug

Administration by intravenous infusion

Primary outcomes

  1. RP2D

    Time frame: through phase IB completion, an average of 5 years

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

  2. Incidence and severity of AE(DLT)

    Time frame: from Day1 to 90 days after last dose

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

  3. ORR

    Time frame: 5 years after the last subject was enrolled in the group

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

Secondary outcomes

  1. DCR

    Time frame: 5 years after the last subject was enrolled in the group

    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;

  2. DOR

    Time frame: 5 years after the last subject was enrolled in the group

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

  3. PFS(Investigator evaluation)

    Time frame: 5 years after the last subject was enrolled in the group

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

  4. OS(Investigator evaluation)

    Time frame: 5 years after the last subject was enrolled in the group

    Since C1D1 and death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Huijie Duan

CONTACT

[email protected]

+86 17721286337

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jul 10, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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