RecruitingPhase 2NCT06378177

A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)

A Phase 2 Study of LVGN6051 Combined With Toripalimab and Paclitaxel for Recurrent/Metastatic HNSCC Rapidly Progressed From Previous Platinum-containing Curative Treatment or Contraindicated for Platinum-containing Treatment

Sponsor

Lyvgen Biopharma Holdings Limited

Enrollment

64 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

Summary

The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LVGN6051, given in combination with other cancer treatments, in people with advanced or metastatic head and neck squamous cell carcinoma (a type of cancer affecting the mouth, throat, voice box, or surrounding areas) that cannot be cured by surgery or local treatment. **You may be eligible if...** - You are 18 or older - You have recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) confirmed by biopsy - Your cancer cannot be surgically removed or cured with local treatment - Your cancer progressed within 6 months of platinum-based chemotherapy, or you have already received standard first-line therapy for metastatic disease **You may NOT be eligible if...** - Your cancer involves a different primary site - You have not tried platinum-based treatment or standard first-line therapy - You have other conditions that would make treatment unsafe 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

BIOLOGICALLVGN6051 Monoclonal Antibody Injection

LVGN6051 Monoclonal Antibody Injection:1 mg/kg or 2 mg/kg, every 3 weeks(Q3W) , on the first day of the treatment cycle for up to 2 years.

BIOLOGICALtoripalimab Injection

toripalimab Injection: 240mg fixed dose,Q3W, on the first day of the treatment cycle for up to 2 years.

DRUGPaclitaxel injection

paclitaxel Injection:5ml:100 mg/m2(80 mg/m2 or 60 mg/m2 can be used if necessary),Q3W,on the first and eighth day of the treatment cycle for up to 2 years

Locations(17)

Anhui Cancer Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Fujian cancer hospital

Fuzhou, Fujian, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Henan cancer hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Liaoning cancer hospital

Shenyang, Liaoning, China

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06378177

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