NCT07105592

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, single-arm, Phase Ib/II clinical trial. Phase Ib uses a 3+3 dose escalation design, and Phase II uses a Simon two-stage design. Phase Ib explores the proper dosage of nimotuzumab to combine with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment. Phase II explores the efficacy and safety of nimotuzumab combined with adebrelimab and chemotherapy in the same patient population. It is expected to enroll approximately 68 subjects with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab+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

Timeline

• Start date: 2025-05-13
• Primary completion: 2027-05-31
• Completion: 2029-05-31
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: China