Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07105592
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: