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RecruitingPhase 2NCT06935188

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

Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in Patients With HPV-negative, Anti-PD-1-resistant Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: An Open Label, Randomized Controlled, Phase II Trial

Sponsor

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

Enrollment

98 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a drug combination — dalpicilib plus cetuximab — against cetuximab alone in patients with head and neck cancer (specifically squamous cell carcinoma) that has a specific genetic pattern. Dalpicilib is a type of cell-cycle blocker, and cetuximab targets a protein called EGFR that drives cancer growth. **You may be eligible if...** - You have squamous cell carcinoma of the head and neck that is recurrent or metastatic - Your tumor has specific genetic characteristics the study is targeting - You have already received prior treatments and your cancer has progressed - You are an adult in adequate overall health **You may NOT be eligible if...** - You have serious uncontrolled infections - You have significant heart problems - You have already received cetuximab and had a severe reaction - You are pregnant or breastfeeding - Your cancer has spread to the brain and is uncontrolled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpicilib 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.

DRUGcetuximab

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.

Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT06935188

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