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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

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.

Trial design

Treatments tested in this trial

  • SHR-A2102
  • Adebrelimab
  • Cetuximab
  • SHR-9839(sc)
  • Carboplatin / Cisplatin

Treatment groups

210 Participants
are divided into 4 treatment groups