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Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC

NCT06935188 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-07-18

No results posted yet for this study

Summary

This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.

Conditions

  • Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Dalpicilib combined with cetuximab

The participants receive cetuximab in combination with Dalpiciclib until termination criteria are met. Participants receive cetuximab intravenously at a dose of 500 mg/m2 biweekly, or an initial dose of 400 mg/m² followed by weekly maintenance dose of 250 mg/m2. Dalpiciclib is administered orally at a dose of 150 mg once daily for 21 consecutive days, followed by a 7-day break. Each 28 days were deemed as a treatment cycle. If the patient vomits or misses a dose, it should not be made up on the same day. The next dose should be taken as usual.

DRUG

cetuximab

The participants receive cetuximab alone until termination criteria are met. Participants receive cetuximab intravenously at a dose of 500 mg/m2 biweekly, or an initial dose of 400 mg/m² followed by weekly maintenance dose of 250 mg/m2.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06935188 on ClinicalTrials.gov