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

NCT07059221 | Recruiting Phase 1

• 1 other identifier: SHR-A2102-211
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• RP2D

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

  through phase IB completion, an average of 5 years

• Incidence and severity of AE(DLT)

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

  from Day1 to 90 days after last dose

• ORR

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

  5 years after the last subject was enrolled in the group

Secondary Outcomes (4)

• DCR

  5 years after the last subject was enrolled in the group

• DOR

  5 years after the last subject was enrolled in the group

• PFS(Investigator evaluation)

  5 years after the last subject was enrolled in the group

• OS(Investigator evaluation)

  5 years after the last subject was enrolled in the group

Study Arms (2)

SHR-A2102+Adebrelimab

EXPERIMENTAL

Drug: SHR-A2102; Drug: Adebrelimab

SHR-A2102+Adebrelimab+Cetuximab

EXPERIMENTAL

Drug: SHR-A2102; Drug: Adebrelimab; Drug: Cetuximab

Interventions

SHR-A2102 DRUG

Administration by intravenous infusion

SHR-A2102+Adebrelimab; SHR-A2102+Adebrelimab+Cetuximab

Adebrelimab DRUG

Administration by intravenous infusion

SHR-A2102+Adebrelimab; SHR-A2102+Adebrelimab+Cetuximab

Cetuximab DRUG

Administration by intravenous infusion

SHR-A2102+Adebrelimab+Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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;
• Presence of necrotic lesions or significant tumor invasion into adjacent organs or blood vessels, as assessed by the investigator, posing a high risk of major bleeding.
• \. 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;
• Last dose of anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, targeted therapy, etc.) within 4 weeksbefore the first dose; for small-molecule targeted drugs, within 2 weeks or 5 half-lives (whichever is longer); traditional Chinese medicine with antitumor indications within 2 weeks before the first dose.
• 、 Uncontrolled or symptomatic active CNS metastases. 7、 Symptomatic visceral metastases with imminent life-threatening complications .
• 、 Known or suspected interstitial lung disease (ILD) or severe pulmonary conditions.
• 、 Other active malignancies within 3 years before study entry. 10、 Clinically significant cardiovascular disease. 11、 Active or chronic infections of clinical significance. 12、 Pregnancy or lactation. 13、 Other factors that, in the investigator's judgment, may lead to premature study discontinuation.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yifan Shen

CONTACT

+86 18801734236; yifan.shen.ys18@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 11, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (2)