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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2029

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
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"

Trial Locations (1)

Unknown

RECRUITING

Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER