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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

• The age of signing the informed consent is \>= 18 years, regardless of gender.

• Subject with advanced or distant metastatic squamous cell carcinoma of the head and neck confirmed by histology or cytology.

• Tumors with primary foci located in the oropharynx, oral cavity, hypopharynx and larynx.

• Provide archived or fresh tumor tissue for test.

• At least one measurable lesion according to RECIST v1.1 criteria.

• The ECOG score is 0 or 1.

• Expected survival ≥12 weeks.

• Good level of organ function.

⁃ Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Contact Information
Primary
Yifan Shen
yifan.shen.ys18@hengrui.com
+86 18801734236
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2028-03
Participants
Target number of participants: 96
Treatments
Experimental: SHR-A2102+Adebrelimab
Experimental: SHR-A2102+Adebrelimab+Cetuximab
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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