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

NCT05721443 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-02-10

No results posted yet for this study

Summary

This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Yue He, M.D. · the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-01-01
Completion
2026-01-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05721443 on ClinicalTrials.gov