RecruitingPhase 1Phase 2NCT07105592

A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma

A Prospective, Phase Ib/II Study of Nimotuzumab Combined With Adebrelimab and Chemotherapy for the Treatment of Patients With Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma Who Are Ineligible to High-Dose Cisplatin

Sponsor

Fudan University

Enrollment

68 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

Summary

This is a prospective, single-arm, Phase Ib/II clinical study to evaluate the safety and efficacy of nimotuzumab combined with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of nimotuzumab (a targeted antibody), adebrelimab (an immunotherapy drug), and chemotherapy for people with head and neck squamous cell carcinoma that has come back or spread, and who cannot safely receive cisplatin (a common but harsh chemotherapy drug). **You may be eligible if...** - You are 18 or older with confirmed recurrent or metastatic head and neck squamous cell carcinoma (not nasopharyngeal cancer) - You have not received any prior systemic treatment after your cancer came back or spread - You are not a good candidate for cisplatin — for example, due to age over 70, poor hearing, kidney problems, or nerve damage - You are in reasonably good health with functional organ systems **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for recurrent or metastatic disease - Your cancer is a nasopharyngeal carcinoma - You have autoimmune disease or are on immunosuppressive therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNimotuzumab+Adebrelimab+Chemotherapy

Phase Ib Treatment Regimen: Nimotuzumab: Three dose groups (200 mg, 400 mg, 600 mg), administered via intravenous infusion over at least 60 minutes, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered via intravenous infusion, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Albumin-bound Paclitaxel: 100 mg/m², administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Carboplatin: AUC=2 (calculated using the Calvert formula), administered intravenously on Days 1 and 8, once every 3 weeks, for 6 cycles. Phase II Treatment Regimen: Nimotuzumab: Recommended Phase II dose (RP2D) as determined from Phase Ib, administered via intravenous infusion on Day 1, once every 3 weeks, until disease progression, intolerable toxicity, or subject withdrawal from the trial. Adebrelimab: Fixed dose of 1200 mg, administered via

Locations(1)

Fudan University

Shanghai, Shanghai Municipality, China

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NCT07105592

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