Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials

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Iparomlimab and Tuvonralimab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Failed Second-line Treatment:A Prospective, Single Arm, Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent/metastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75 years, regardless of gender; Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (with primary tumor sites in the oropharynx, oral cavity, hypopharynx, and larynx), with clinical or radiological progression after receiving 2 or more lines of anti-tumor systemic therapy in the recurrent or metastatic stage; ECOG performance status of 0 or 1; Expected survival period ≥ 12 weeks; At least one measurable lesion according to RECIST 1.1 criteria. Lesions that have undergone previous radiotherapy can be used as measurable lesions if disease progression occurs; Availability of tumor tissue for PD-L1 detection (paraffin-embedded specimens within 2 years or fresh tumor tissue); For patients with oropharyngeal cancer, the P16 detection status, determined by IHC method;

⁃ Normal function of major organs within 2 weeks before treatment, meeting the following criteria:

⁃ Bone marrow function: Hemoglobin ≥ 100g/L, white blood cell count ≥ 4.0×10\^9/L or neutrophil count ≥ 2.0×10\^9/L, and platelet count ≥ 100×10\^9/L without blood transfusion or colony-stimulating factor support; Liver function: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times the upper limit of normal; Renal function: Serum creatinine level \< 1.5 times the upper limit of normal or creatinine clearance rate ≥ 60ml/min, and blood urea nitrogen ≤ 200mg/L; Urinary protein \< +; if urinary protein is +, the 24-hour total protein must be \< 500mg; Blood glucose: Within the normal range and/or for diabetic patients, blood glucose is controlled in a stable state during treatment; Cardiac function: No myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency; For women of childbearing age, the serum pregnancy test result must be negative within 7 days before the first administration of the trial drug; males with reproductive capacity or females with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) throughout the trial, and continue contraception for 12 months after the end of treatment.

⁃ Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; Patients whom doctors believe can benefit from the treatment.

Locations
Other Locations
China
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Guoxin Ren, M.D.
renguoxincn@sina.com
13916948812
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 30
Treatments
Experimental: Iparomlimab and Tuvonralimab
The administration regimen of Iparomlimab and Tuvonralimab is: the recommended dose of Iparomlimab and Tuvonralimab is 5mg/kg, intravenous infusion, with a treatment cycle of 21 days. The subjects will continue to receive treatment with Iparomlimab and Tuvonralimab until the termination criteria are met.
Sponsors
Leads: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

This content was sourced from clinicaltrials.gov