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

NCT07105592 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dongmei Ji, doctor · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2027-05-31
Completion
2029-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105592 on ClinicalTrials.gov