Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 1, 2023

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2026

Conditions
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Dalpiciclib+cetuximab

"The dosing regimen for cetuximab combined with dalpiciclib is: the starting dose of cetuximab is 400 mg/m2, titrated over 120 minutes, and the titration rate should be limited to 5 ml/min. A maintenance dose of 250 mg/m2, titrated over not less than 60 minutes, with pretreatment with H1 receptor blocker desensitization prior to dosing, administered once weekly.~The recommended dose of dalpiciclib is 150 mg once daily for 21 days, followed by 7 days of discontinuation (3/1 dosing regimen) for a 28-day treatment cycle. Take the drug at approximately the same time each day. If the patient vomits or misses a dose, the dose should not be made up that day. The next dose should be taken as usual.~Subjects will continue treatment with cetuximab in combination with dalpiciclib until termination criteria are met."

Trial Locations (1)

200011

RECRUITING

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER